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Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices

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Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final amendment; final order.

SUMMARY:

The Food and Drug Administration (FDA, Agency, or we) identified a list of class I devices and class II devices that are now exempt from premarket notification requirements, subject to certain limitations. FDA published the lists of final determinations in accordance with procedures established by the 21st Century Cures Act (Cures Act). Although each classification regulation for each such type of device shall be deemed amended to incorporate such exemption, we are publishing this final order to amend the codified language for each listed class I and class II device's classification regulation to reflect the final determinations. FDA's action decreases regulatory burden on the medical device industry and eliminates private costs and expenditures required to comply with certain Federal regulations.

DATES:

This order is effective December 30, 2019.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Karen Fikes, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5502, Silver Spring, MD 20993, 301-796-9603, email: karen.fikes@fda.hhs.gov.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

I. Background

The Cures Act (Pub. L. 114-255) was signed into law on December 13, 2016. Under the Cures Act, section 3054 amended section 510(l) and (m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360(l) and (m)). As amended, section 510(l)(2) of the FD&C Act requires FDA to identify through publication in the Federal Register, any type of class I device that the Agency determines no longer requires a report under section 510(k) of the FD&C Act to provide reasonable assurance of safety and effectiveness. Start Printed Page 71795FDA shall publish this determination within 120 days of the date of enactment of the Cures Act and at least once every 5 years thereafter, as FDA determines appropriate. Further, section 510(l)(2) provides that upon the date of publication of the Agency's determination in the Federal Register, a 510(k) will no longer be required for these devices and the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption.

As amended, section 510(m)(1)(A) of the FD&C Act provides that, within 90 days after enactment of the Cures Act and at least once every 5 years thereafter, FDA shall publish in the Federal Register a notice containing a list of each type of class II device that FDA determines no longer requires a report under section 510(k) of the FD&C Act to provide reasonable assurance of safety and effectiveness. This notice shall provide at least a 60-day comment period. Within 210 days of enactment of the Cures Act, FDA shall publish in the Federal Register a list representing its final determination regarding exemption of devices that were contained in the proposed list published under 510(m)(1)(A) of the FD&C Act. Further, section 510(m)(3) of the FD&C Act provides that upon the date of publication of the final list in the Federal Register, a 510(k) will no longer be required for these devices and the classification regulation applicable to each such device shall be deemed amended to incorporate such exemption.

In the Federal Register of April 13, 2017 (82 FR 17841), in accordance with the amendments to 510(l)(2), FDA issued a notice of final determination to exempt a list of class I devices from premarket notification requirements under section 510(k) of the FD&C Act, subject to certain limitations. In the Federal Register of March 14, 2017 (82 FR 13609), in accordance with the amendments to 510(m)(1)(A), FDA issued a notice proposing to exempt a list of class II devices from premarket notification requirements under section 510(k) of the FD&C Act, subject to certain limitations. After a 60-day comment period, in the Federal Register of July 11, 2017 (82 FR 31976), FDA issued a notice of final determination to exempt class II devices provided in the proposed list. Through this action, FDA is now amending the codified language for each listed classification regulation to reflect final determinations for these class I and class II exemptions.[1]

Following publication of the notices, FDA determined that it is unnecessary to update three classification regulations (21 CFR 872.4565, 21 CFR 878.4014, and 21 CFR 880.6320) included in the class I notice, 82 FR 17841. Five product codes corresponding to these three classification regulations (EGI and EIB (21 CFR 872.4565), OVR (21 CFR 878.4014), KZF and PEQ (21 CFR 880.6320)) were identified for exemption in 82 FR 17841; however, the corresponding classification regulations were already class I, exempt from premarket notification procedures in subpart E of part 807 (21 CFR part 807, subpart E) subject to the limitations in the corresponding “.9” regulations (i.e., 21 CFR 872.9, 21 CFR 878.9 or 21 CFR 880.9); and, therefore, no revisions to the codified are necessary. Additionally, we determined that it is unnecessary to update 21 CFR 876.5820 included in the class II notice, 82 FR 13609. The product code within this classification regulation (FKI) was identified for exemption in 82 FR 13609. However, this device type is specifically identified within the class I paragraph of this classification regulation (21 CFR 876.5820(b)(2)) and already exempt from premarket notification procedures in subpart E of part 807 subject to the limitations in 21 CFR 876.9. Therefore, no revisions to the codified are necessary.

We are also making a revision to correct a misidentified classification regulation in 82 FR 31976. The notice incorrectly listed the classification regulation 21 CFR 868.1400 “Carbon dioxide gas analyzer” as corresponding with product code LLK; however, the correct classification regulation associated with product code LLK is 21 CFR 880.5780 “Medical Support Stocking”. Therefore, 21 CFR 868.1400 remains unchanged, and 21 CFR 880.5780(a)(2) is revised to reflect the exemption.

We are revising the name of one classification regulation, currently entitled “Urological clamp for males”, in response to FDA's exemption in 82 FR 17841. Part 876.5160 is currently entitled “Urological clamp for males,” which was previously exempt from premarket notification procedures “. . . Except when intended for internal use or use on females . . .”. In 82 FR 17841, we exempted product code MNG, “External Urethral Occluder, Urinary Incontinence-Control, Female” and removed the current limitation language regarding “use on females.” Therefore, FDA is revising the name of the classification regulation to read “Urological clamp” to ensure clarity.

II. Criteria for Exemption

As amended by the Cures Act, section 510(l) now has two provisions, 510(l)(1) and (2). Under 510(1)(1), a class I device is exempt from the premarket notification requirements under section 510(k) of the FD&C Act, unless the device is intended for a use which is of substantial importance in preventing impairment of human health or it presents a potential unreasonable risk of illness or injury. Based on these criteria, FDA evaluated all class I devices to determine which device types should be exempt from premarket notification requirements.

For class II devices, there are a number of factors FDA may consider to determine whether a 510(k) is necessary to provide reasonable assurance of the safety and effectiveness of a class II device. These factors are discussed in the January 21, 1998, Federal Register notice (63 FR 3142) and subsequently in the guidance we issued on February 19, 1998, entitled “Procedures for Class II Device Exemptions From Premarket Notification, Guidance for Industry and CDRH Staff ”.[2]

III. Limitations on Exemptions

Although FDA exempted the types of class I and class II devices from the premarket notification requirements under section 510(k) of the FD&C Act in accordance with the provisions under 510(l) and (m), an exemption from the requirement of premarket notification does not mean the device is exempt from any other statutory or regulatory requirements, unless such exemption is explicitly provided by order or regulation. FDA's determination that premarket notification is unnecessary to provide a reasonable assurance of safety and effectiveness is based, in part, on the assurance of safety and effectiveness that other regulatory controls, such as current good manufacturing practice requirements, provide.

In addition to being subject to the general limitations to the exemptions found in 21 CFR 862.9 to 892.9, FDA has also partially limited some exemptions from premarket notification requirements to specific devices within Start Printed Page 71796the listed device type. In such situations where a partial exemption limitation has been identified, FDA has determined that premarket notification is necessary to provide a reasonable assurance of safety and effectiveness for these devices.

IV. Analysis of Environmental Impact

The Agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

V. Paperwork Reduction Act of 1995

This final order refers to previously approved FDA collections of information. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR parts 801 and 809, regarding labeling, have been approved under OMB control number 0910-0485; and the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073.

Start List of Subjects

List of Subjects

21 CFR Parts 862, 868, 870, 872, 874, 876, 878, 880, 882, 884, 888, and 890

  • Medical devices

21 CFR Part 864

  • Blood
  • Medical devices
  • Packaging and Containers

21 CFR Part 866

  • Biologics
  • Laboratories
  • Medical devices

21 CFR Part 886

  • Medical devices
  • Ophthalmic goods and services

21 CFR Part 892

  • Medical devices
  • Radiation protection
  • X-rays
End List of Subjects

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888, 890, and 892 are amended as follow:

Start Part

PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

End Part Start Amendment Part

1. The authority citation for part 862 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

End Authority Start Amendment Part

2. In § 862.1020, revise paragraph (b) to read as follows:

End Amendment Part
Acid phosphatase (total or prostatic) test system.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Start Amendment Part

3. In § 862.1090, revise paragraph (b) to read as follows:

End Amendment Part
Angiotensin converting enzyme (A.C.E.) test system.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Start Amendment Part

4. In § 862.1100, revise paragraph (b) to read as follows:

End Amendment Part
Aspartate amino transferase (AST/SGOT) test system.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Start Amendment Part

5. In § 862.1150, revise paragraph (b) to read as follows:

End Amendment Part
Calibrator.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Start Amendment Part

6. In § 862.1345, revise paragraph (b) to read as follows:

End Amendment Part
Glucose test system.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Start Amendment Part

7. In § 862.1350, revise paragraph (b) introductory text to read as follows:

End Amendment Part
Continuous glucose monitor secondary display.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The special controls for this device are:

* * * * *
Start Amendment Part

8. In § 862.1410, revise paragraph (b) to read as follows:

End Amendment Part
Iron (non-heme) test system.
* * * * *

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Start Amendment Part

9. In § 862.1415, revise paragraph (b) to read as follows:

End Amendment Part
Iron-binding capacity test system.
* * * * *

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Start Amendment Part

10. In § 862.1445, revise paragraph (b) to read as follows:

End Amendment Part
Lactate dehydrogenase isoenzymes test system.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Start Amendment Part

11. In § 862.1509, revise paragraph (b) to read as follows:

End Amendment Part
Methylmalonic acid (nonquantitative) test system.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Start Amendment Part

12. In § 862.1580, revise paragraph (b) to read as follows:

End Amendment Part
Phosphorous (inorganic) test system.
* * * * *

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Start Amendment Part

13. In § 862.1660, revise paragraph (b) to read as follows:

End Amendment Part
Quality control material (assayed and unassayed).
* * * * *

(b) Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are Start Printed Page 71797exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Start Amendment Part

14. In § 862.1685, revise paragraph (b) as follows:

End Amendment Part
Thyroxine-binding globulin test system.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Start Amendment Part

15. In § 862.1700, revise paragraph (b) as follows:

End Amendment Part
Total thyroxine test system.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Start Amendment Part

16. In § 862.1775, revise paragraph (b) to read as follows:

End Amendment Part
Uric acid test system.
* * * * *

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Start Amendment Part

17. In § 862.2265, revise paragraph (b) introductory text to read as follows:

End Amendment Part
High throughput genomic sequence analyzer for clinical use.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The special controls for this device are:

* * * * *
Start Amendment Part

18. In § 862.2570, revise paragraph (b) to read as follows:

End Amendment Part
Instrumentation for clinical multiplex test systems.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems.” See § 862.1(d) for the availability of this guidance document.

Start Amendment Part

19. In § 862.3050, revise paragraph (b) to read as follows:

End Amendment Part
Breath-alcohol test system.
* * * * *

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Start Amendment Part

20. In § 862.3100, revise paragraph (b) to read as follows:

End Amendment Part
Amphetamine test system.
* * * * *

(b) Classification. Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Start Amendment Part

21. In § 862.3150, revise paragraph (b) to read as follows:

End Amendment Part
Barbiturate test system.
* * * * *

(b) Classification. Class II (special controls). A barbiturate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Start Amendment Part

22. In § 862.3170, revise paragraph (b) to read as follows:

End Amendment Part
Benzodiazepine test system.
* * * * *

(b) Classification. Class II (special controls). A benzodiazepine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Start Amendment Part

23. In § 862.3200, revise paragraph (b) to read as follows:

End Amendment Part
Clinical toxicology calibrator.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Start Amendment Part

24. In § 862.3220, revise paragraph (b) to read as follows:

End Amendment Part
Carbon monoxide test system.
* * * * *

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Start Amendment Part

25. In § 862.3240, revise paragraph (b) to read as follows:

End Amendment Part
Cholinesterase test system.
* * * * *

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Start Amendment Part

26. In § 862.3250, revise paragraph (b) to read as follows:

End Amendment Part
Cocaine and cocaine metabolite test system.
* * * * *

(b) Classification. Class II (special controls). A cocaine and cocaine metabolite test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., Start Printed Page 71798programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Start Amendment Part

27. In § 862.3270, revise paragraph (b) to read as follows:

End Amendment Part
Codeine test system.
* * * * *

(b) Classification. Class II (special controls). A codeine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Start Amendment Part

28. In § 862.3280, revise paragraph (b) to read as follows:

End Amendment Part
Clinical toxicology control material.
* * * * *

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Start Amendment Part

29. In § 862.3580, revise paragraph (b) to read as follows:

End Amendment Part
Lysergic acid diethylamide (LSD) test system.
* * * * *

(b) Classification. Class II (special controls). A lysergic acid diethylamide (LSD) test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Start Amendment Part

30. In § 862.3610, revise paragraph (b) to read as follows:

End Amendment Part
Methamphetamine test system.
* * * * *

(b) Classification. Class II (special controls). A methamphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Start Amendment Part

31. In § 862.3620, revise paragraph (b) to read as follows:

End Amendment Part
Methadone test system.
* * * * *

(b) Classification. Class II (special controls). A methadone test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Start Amendment Part

32. In § 862.3630, revise paragraph (b) to read as follows:

End Amendment Part
Methaqualone test system.
* * * * *

(b) Classification. Class II (special controls). A methaqualone test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Start Amendment Part

33. In § 862.3640, revise paragraph (b) to read as follows:

End Amendment Part
Morphine test system.
* * * * *

(b) Classification. Class II (special controls). A morphine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Start Amendment Part

34. In § 862.3650, revise paragraph (b) to read as follows:

End Amendment Part
Opiate test system.
* * * * *

(b) Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Start Amendment Part

35. In § 862.3700, revise paragraph (b) to read as follows:

End Amendment Part
Propoxyphene test system.
* * * * *
Start Printed Page 71799

(b) Classification. Class II (special controls). A propoxyphene test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Start Amendment Part

36. In § 862.3870, revise paragraph (b) to read as follows:

End Amendment Part
Cannabinoid test system.
* * * * *

(b) Classification. Class II (special controls). A cannabinoid test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Start Amendment Part

37. In § 862.3910, revise paragraph (b) to read as follows:

End Amendment Part
Tricyclic antidepressant drugs test system.
* * * * *

(b) Classification. Class II (special controls). A tricyclic antidepressant drugs test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Start Part

PART 864—HEMATOLOGY AND PATHOLOGY DEVICES

End Part Start Amendment Part

38. The authority citation for part 864 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

End Authority Start Amendment Part

39. In § 864.5400, revise paragraph (b) to read as follows:

End Amendment Part
Coagulation instrument.
* * * * *

(b) Classification. Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Start Amendment Part

40. In § 864.5425, revise paragraph (b) to read as follows:

End Amendment Part
Multipurpose system for in vitro coagulation studies.
* * * * *

(b) Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Start Amendment Part

41. In § 864.6550, revise paragraph (b) to read as follows:

End Amendment Part
Occult blood test.
* * * * *

(b) Classification. Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Start Amendment Part

42. In § 864.7040, revise paragraph (b) to read as follows:

End Amendment Part
Adenosine triphosphate release assay.
* * * * *

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Start Amendment Part

43. In § 864.7275, revise paragraph (b) to read as follows:

End Amendment Part
Euglobulin lysis time tests.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Start Amendment Part

44. In § 864.7300, revise paragraph (b) to read as follows:

End Amendment Part
Fibrin monomer paracoagulation test.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. The special control for this device is FDA's “In Vitro Diagnostic Fibrin Monomer Paracoagulation Test.” See § 864.1(d) for information on obtaining this document.

Start Amendment Part

45. In § 864.7340, revise paragraph (b) to read as follows:

End Amendment Part
Fibrinogen determination system.
* * * * *

(b) Classification. Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Start Amendment Part

46. In § 864.7375, revise paragraph (b) to read as follows:

End Amendment Part
Glutathione reductase assay.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Start Amendment Part

47. In § 864.7415, revise paragraph (b) to read as follows:

End Amendment Part
Abnormal hemoglobin assay.
* * * * *

(b) Classification. Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Start Amendment Part

48. In § 864.7455, revise paragraph (b) to read as follows:

End Amendment Part
Fetal hemoglobin assay.
* * * * *

(b) Classification. Class II (special controls). A fetal hemoglobin stain intended for use with a fetal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Start Amendment Part

49. In § 864.7500, revise paragraph (b) to read as follows:

End Amendment Part
Start Printed Page 71800
Whole blood hemoglobin assays.
* * * * *

(b) Classification. Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Start Amendment Part

50. In § 864.7720, revise paragraph (b) to read as follows:

End Amendment Part
Prothrombin consumption test.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Start Amendment Part

51. In § 864.7735, revise paragraph (b) to read as follows:

End Amendment Part
Prothrombin-proconvertin test and thrombotest.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Start Amendment Part

52. In § 864.8150, revise paragraph (b) to read as follows:

End Amendment Part
Calibrator for cell indices.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Start Amendment Part

53. In § 864.8165, revise paragraph (b) to read as follows:

End Amendment Part
Calibrator for hemoglobin or hematocrit measurement.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Start Amendment Part

54. In § 864.8175, revise paragraph (b) to read as follows:

End Amendment Part
Calibrator for platelet counting.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Start Amendment Part

55. In § 864.8185, revise paragraph (b) to read as follows:

End Amendment Part
Calibrator for red cell and white cell counting.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Start Amendment Part

56. In § 864.8625, revise paragraph (b) to read as follows:

End Amendment Part
Hematology quality control mixture.
* * * * *

(b) Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Start Amendment Part

57. In § 864.9400, revise paragraph (b) to read as follows:

End Amendment Part
Stabilized enzyme solution.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Start Part

PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES

End Part Start Amendment Part

58. The authority citation for part 866 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

End Authority Start Amendment Part

59. In § 866.2900, revise paragraph (b) to read as follows:

End Amendment Part
Microbiological specimen collection and transport device.
* * * * *

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

Start Amendment Part

60. In § 866.3395, revise paragraph (b) to read as follows:

End Amendment Part
Norovirus serological reagents.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Norovirus Serological Reagents.” See § 866.1(e) for the availability of this guidance document.

Start Amendment Part

61. In § 866.5210, revise paragraph (b) to read as follows:

End Amendment Part
Ceruloplasmin immunological test system.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

Start Amendment Part

62. In § 866.5470, revise paragraph (b) to read as follows:

End Amendment Part
Hemoglobin immunological test system.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

Start Amendment Part

63. In § 866.5620, revise paragraph (b) to read as follows:

End Amendment Part
Alpha-2-macroglobulin immunological test system.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

Start Amendment Part

64. In § 866.5630, revise paragraph (b) to read as follows:

End Amendment Part
Beta-2-microglobulin immunological test system.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

Start Amendment Part

65. In § 866.5750, revise paragraph (b) to read as follows:

End Amendment Part
Radioallergosorbent (RAST) immunological test system.
* * * * *

(b) Classification. Class II (special controls). The device, when intended to detect any of the allergens included in Table 1 in this paragraph, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.Start Printed Page 71801

Table 1—Class II Exempt Allergens Under § 866.5750—Radioallergosorbent (RAST) Immunological Test Systems

Allergen codeAllergen productSource (taxonomical name)
Grass Pollens
g1Sweet vernal grassAnthoxanthum odoratum.
g3Cocksfoot grass, Orchard grassDactylis glomerata.
g4Meadow fescueFestuca elatior.
g5Rye-grass (perennial rye grass)Lolium perenne.
g7Common reed (common reed grass)Phragmites communis.
g8Meadow grass, Kentucky blue (June grass)Poa pratensis.
g9Redtop, BentgrassAgrostis stolonifera, Agrostis gigantea (Agrostis alba).
g11Brome grassBromus inermis.
g12Cultivated rye (cultivated rye grass)Secale cereale.
g13Velvet grassHolcus lanatus.
g14Cultivated oat (cultivated oat grass)Avena sativa.
g15Cultivated wheat (cultivated wheat grass)Triticum aestivum (Triticum spp.).
g16Meadow foxtail (meadow foxtail grass)Alopecurus pratensis.
g17Bahia grassPaspalum notatum.
g24Wheat grass, WesternAgropyron smithii (Elymus smithii).
g30Bluegrass, annualPoa annua.
g70Wild rye grassElymus triticoides Elymus condensatus.
g71Canary grassPhalaris arundinacea.
g201Barley, cultivatedHordeum vulgare.
g202Maize, corn (cultivated corn)Zea mays.
g203Salt grassDistichlis spicata.
g204False oat-grassArrhenatherum elatius.
g216Cyn d 1Cynodon dactylon.
g701Phl p 1.0102, Phl p 5.0101Phleum pratense.
g702Phl p 7.0101Phleum pratense.
g703Phl p 12.0101Phleum pratense.
Weed Pollens
w2Western ragweedAmbrosia psilostachya.
w4False ragweedAmbrosia acanthicarpa (Franseria acanthicarpa).
w5WormwoodArtemisia absinthium Artemisia annua.
w6MugwortArtemisia vulgaris.
w7Marguerite, ox-eye daisyChrysanthemum leucanthemum.
w8DandelionTaraxacum vulgare, Taraxacum officinale.
w9Plantain (English), RibwortPlantago lanceolata.
w10Goosefoot, lamb's quartersChenopodium album.
w11Saltwort (prickly), Russian thistleSalsola kali (Salsola pestifer).
w12GoldenrodSolidago virgaurea (Solidago spp.).
w13Cocklebur, commonXanthium commune.
w14Common pigweed (rough pigweed)Amaranthus retroflexus.
w15Scale, LenscaleAtriplex lentiformis.
w16Rough marsh elderIva ciliate, Iva annua.
w17Firebush (Kochia)Kochia scoparia.
w18Sheep sorrelRumex acetosella.
w19Wall pellitoryParietaria officinalis.
w20Nettle (Common stinging nettle)Urtica dioica.
w21Wall pellitoryParietaria judaica.
w22Japanese hop (careless weed)Humulus japonicas (Humulus scandens).
w23Yellow dock, Yellow dockweedRumex crispus.
w24Spiny pigweedAmaranthus spinosus.
w27CarnationDianthus spp.
w28RoseRosa rugosa.
w33CloverTrifolium pratense.
w35Mexican teaChenopodium ambrosioides.
w36Rabbit bushAmbrosia deltoidea (Franseria deltoides).
w37Salt bush, annualAtriplex wrightii.
w39Water hemp, WesternAmaranthus rudis (Acnida tamariscina).
w41BurrobrushHymenoclea salsola.
w42Poverty weedBaccharis neglecta.
w43Common sagebrushArtemisia tridentata.
w45AlfalfaMedicago sativa.
w46Dog fennelEupatorium capillifolium.
w53GeraniumGeranium spp.
w67Groundsel bushBaccharis halimifolia.
w69Iodine bushAllenrolfea occidentalis.
w70Ragweed, slenderAmbrosia confertiflora.
w75Wing scale (wingscale)Atriplex canescens.
Start Printed Page 71802
w82Careless weedAmaranthus palmeri, Amaranthus hybridus.
w90Japanese hopHumulus japonicas (Humulus scandens).
w203Rape (rape pollen)Brassica napus.
w204SunflowerHelianthus annuus.
w206CamomileMatricaria chamomilla.
w207LupinLupinus spp.
w210Sugar-beetBeta vulgaris.
w211Par j 2.0101Parietaria judaica.
w231Art v 1Artemisia vulgaris (Mugwort).
w232Sal k 1Salsola kali.
w233Art v 3Artemisa vulgaris (LTP, Mugwort).
w234Pla l 1Plantago lanceolata.
w235Che a 1.0101Chenopodium album.
w236Mer a 1.0101Mercurialis annua.
a753Art v 1Artemisia vulgaris (Mugwort weed).
Tree Pollens
t1Box-elder (Maple)Acer negundo, Acer saccharum.
t2Gray alder, speckled alder (alder)Alnus incana.
t4Hazel, hazelnutCorylus avellana, Corylus americana.
t5American beech (beech)Fagus grandifolia (Fagus americana).
t6Mountain juniper, Mountain cedarJuniperus ashei (Juniperus sabinoides).
t8ElmUlmus americana.
t9OliveOlea europaea.
t10WalnutJuglans californica, Juglans nigra.
t11Maple leaf sycamore, London plane, Plane treePlatanus acerifolia.
t61SycamorePlatanus occidentalis.
t12WillowSalix caprea, Salix nigra.
t14Cottonwood (Eastern Cottonwood/Black Cottonwood)Populus deltoides.
t15White ashFraxinus americana.
t16White pinePinus strobus.
t18Eucalyptus, gum-treeEucalyptus globulus (Eucalyptus spp.).
t19/t26AcaciaAcacia longifolia (Acacia spp.).
t20MesquiteProsopis glandulosa/ Prosopis juliflora.
t21Melaleuca, cajeput treeMelaleuca quinquenervia (Melaleuca leucadendron).
t22Pecan, hickoryCarya illinoinensis (Carya pecan).
t23Italian/Mediterranean/funeral cypressCupressus sempervirens.
t24Japanese cypressChamaecyparis obtusa (Chamaecyparis spp.).
t25AshFraxinus excelsior.
t27Maple, redAcer rubrum.
t29AcaciaAcacia spp.
t30Birch, whiteBetula populifolia.
t32Willow, blackSalix nigra.
t33Ash, ArizonaFraxinus velutina.
t35Cedar, saltTamarix gallica.
t37Bald cypress (white bald cypress)Taxodium distichum.
t38Elm, Chinese/SiberianUlmus pumila.
t40Hazelnut treeCorylus americana.
t41White hickoryCarya alba (Carya tomentosa).
t42Oak, redQuercus rubra.
t43Loblolly pinePinus taeda.
t44HackberryCeltis occidentalis.
t45Cedar elmUlmus crassifolia.
t47Juniper, one seedJuniperus monosperma.
t48Pine, lodgepolePinus contorta.
t49Pine, ponderosaPinus ponderosa.
t50Beech, EuropeanFagus sylvatica.
t51Tree of HeavenAilanthus altissima.
t52Western white pinePinus monticola.
t54Russian oliveElaeagnus angustifolia.
t55Scotch broomCytisus scoparius.
t56BayberryMyrica cerifera.
t57Red cedarJuniperus virginiana.
t60Western juniperJuniperus occidentalis.
t61SycamorePlatanus occidentalis.
t70Mulberry (white mulberry)Morus alba.
t71Red mulberryMorus rubra.
t72Queen palmArecastrum romanzoffiamon.
t73Australian pineCasuarina equisetifolia.
Start Printed Page 71803
t77Oak mix (red, white, black)Quercus spp.
t80Japanese cypressChamaecyparis obtusa.
t81Japanese alderAlnus japonica.
t83Mango treeMangifera indica.
t90Walnut, blackJuglans nigra.
t96Poplar, white (poplar)Populus alba.
t103/t218Virginia live oak (live oak)Quercus virginiana.
t105Pepper treeSchinus molle.
t110Orange treeCitrus sinensis.
t201Spruce, Norway sprucePicea abies (Picea excelsa).
t202Alder, smoothAlnus incana spp. Rugosa (Alnus rugosa).
t203Horse chestnutAesculus hippocastanum.
t205ElderSambucus nigra.
t206ChestnutCastanea sativa.
t207Douglas firPseudotsuga menziesii (Pseudotsuga taxifolia).
t208LindenTilia cordata.
t209Horn beamCarpinus betulus.
t210PrivetLigustrum vulgare.
t211Sweet gumLiquidambar styraciflua.
t212CedarLibocedrus decurrens.
t213PinePinus radiata.
t214Date palmPhoenix canariensis.
t215LilacSyringa vulgaris.
t217Pepper treeSchinus molle.
t217Red alderAlnus rubra.
t218Virginia live oakQuercus virginiana.
t218Bayberry (bayberry/sweet gale)Myrica gale.
t219Palo verdeCercidium floridum.
t219Red cedarJuniperus virginiana.
t220Bet v 4Betula verrucosa (Birch).
t221Bet v 2.0101, Bet v 4Betula verrucosa (Birch).
t222Cypress (Arizona cypress)Cupressus arizonica.
t223Oil palmElaeis guineensis.
t224Ole e 1Olea europaea.
t225Bet v 6Betula verrucosa (Birch).
t226Cup a 1Cupressus arizonica.
t227Ole e 7Olea Europaea.
t228Aspen, quakingPopulus tremuloides.
t229Eastern hemlockTsuga canadensis.
t230Redwood (sequoia)Sequoia sempervirens.
t232Pussy willowSalix discolor.
t240Ole e 9.0101Olea Europaea.
t241Pla a 1.0101Platanus acerifolia.
t242Pla a 2Platanus acerifolia.
t243Pla a 3.0101Platanus acerifolia.
t244Cor a 1.0103Corylus avellana.
t245Aln g 1.0101Alnus glutinosa.
t246Cry j 1Cryptomeria japonica.
t280Locust treeRobinia pseudoacacia.
t401Brazilian peppertreeSchinus terebinthifolius.
t402Mastic treePistacia lentiscus.
t404Tree of heavenAilanthus altissima.
t406Date palmPhoenix dactylifera.
a482Ole e 1Olea europaea (Olive Oil).
Mites
d207Blo t 5.0101Blomia tropicalis.
d208Lep d 2.0101Lepidoglyphus destructor.
Microorganisms, Molds, Yeast
m1Penicillium chrysogenum (Penicillium notatum)Penicillium chrysogenum (Penicillium notatum).
m2Cladosporium herbarum (Hormodendrum)Cladosporium herbarum (Hormodendrum).
m3Aspergillus fumigatusAspergillus fumigatus.
m4Mucor racemosusMucor racemosus.
m5Candida albicansCandida albicans.
m7Botrytis cinereaBotrytis cinerea.
m8Drechslera halodes (Setomelanomma rostrata, Helminthosporium halodes, Helminthosporium interseminatum)Drechslera halodes (Setomelanomma rostrata, Helminthosporium halodes.
Start Printed Page 71804
m9Fusarium moniliforme (Fusarium proliferatum)Fusarium moniliforme (Fusarium proliferatum).
m10Stemphylium botryosumStemphylium herbarum (Stemphylium botryosum).
m11Rhizopus nigricansRhizopus nigricans.
m12Aureobasidium pullulansAureobasidium pullulans.
m13Phoma betaePhoma betae.
m14Epicoccum purpurascensEpicoccum purpurascens (Epicoccum nigrum).
m15Trichoderma virideTrichoderma viride.
m16Curvularia lunataCurvularia lunata, Curvularia specifera (K923044).
m17Cladosporium fulvumCladosporium fulvum.
m18Fusarium culmorumFusarium culmorum.
m19Aspergillus versicolorAspergillus versicolor.
m20Mucor mucedoMucor mucedo.
m21Aspergillus clavatusAspergillus clavatus.
m22Micropolyspora faeniSaccharopolyspora rectivirgula (Micropolyspora faeni).
m23Thermoactinomyces vulgarisThermoactinomyces vulgaris.
m24Stachybotrys atraStachybotrys chartarum (Stachybotrys atra).
m24Paecilomyces sppPaecilomyces spp.
m25Aspergillus versicolorAspergillus versicolor.
m25Penicillium brevicompactumPenicillium brevicompactum.
m26Cladosporium cladosporioidesCladosporium cladosporioides.
m26Penicillium citrinumPenicillium citrinum.
m27Penicillium sppPenicillium spp.
m29Aspergillus repensAspergillus repens.
m30Penicillium roquefortiPenicillium roqueforti.
m32Cladosporium cladosporioidesCladosporium cladosporioides.
m34Serpula lacrymansSerpula lacrymans.
m36Aspergillus terreusAspergillus terreus.
m37Trichophyton mentagrophytesTrichophyton mentagrophytes.
m40Aspergillus amstelodamiAspergillus amstelodami.
m43Saccharomyces CarlsbergSaccharomyces carlsbergensis.
m44Saccharomyces cerevisiaeSaccharomyces cerevisiae.
m45Hormodendrum hordeiHormodendrum hordei.
m46Bipolaris spiciferaBipolaris spicifera.
m47Aspergillus nidulansAspergillus nidulans.
m48Aspergillus oryzaeAspergillus oryzae.
m49Fusarium oxysporumFusarium oxysporum.
m50Micropolyspora faeniSaccharopolyspora rectivirgula (Micropolyspora faeni).
m51Thermoactinomyces vulgarisThermoactinomyces vulgaris.
m53Microspora canisMicrosporum canis (Microspora canis).
m54Aspergillus flavusAspergillus flavus.
m63Helminthosporium interseminHelminthosporium intersemin.
m66Mucor plumbeusMucor plumbeus.
m67MycogoneMycogone perniciosa.
m68Nigrospora oryzaeNigrospora oryzae.
m69RhodotorulaRhodotorula rubra (Rhodotorula mucilaginosa).
m70Malassezia furfur (Pityrosporum orbiculare)Malassezia furfur (Pityrosporum orbiculare).
m71SpondylocladiumSpondylocladium spp.
m72EpidermophytonEpidermophyton floccosum.
m73Epicoccum nigrumEpicoccum purpurascens (Epicoccum nigrum).
m80Staphylococcal enterotoxin A (Sta a SEA)Staphylococcus aureus.
m80Helminthosporium sppHelminthosporium spp.
m81Staphylococcal enterotoxin B (Sta a SEB)Staphylococcus aureus.
m88Stemphylium solaniStemphylium solani.
m93Gliocladium fimbriatumGliocladium fimbriatum.
m94Phycomyces blakesleeanusPhycomyces blakesleeanus.
m201Tilletia tritici (Ustilago nuda, Ustilago tritici) (Barley smut)Tilletia tritici (Ustilago nuda, Ustilago tritici).
m202Acremonium kiliense (Cephalosporium acremonium)Acremonium kiliense (Cephalosporium acremonium).
m203Trichosporon pullulansTrichosporon pullulans.
m204Ulocladium chartarumUlocladium chartarum.
m205Trichophyton rubrumTrichophyton rubrum.
m207Aspergillus nigerAspergillus niger.
m208Chaetomium globosumChaetomium globosum.
m209Penicillium frequentansPenicillium glabrum (Penicillium frequentans).
m209Stachybotrys chartarumStachybotrys chartarum (Stachybotrys atra).
m210Trichophyton mentagrophytes var. goetziiTrichophyton mentagrophytes var. goetzii.
m211Trichophyton mentagrophytes var. interdigitaleTrichophyton mentagrophytes var. interdigitale.
m211Oat smutUstilago avenae.
m212Micropolyspora faeniSaccharopolyspora rectivirgula (Micropolyspora faeni).
m212Geotrichum candidumGeotrichum candidum.
m213Bermuda grass smutUstilago cynodontis.
Start Printed Page 71805
m214Johnson grass smutSphacelotheca cruenta.
m215Corn smutUstilago maydis.
m218Asp f 1.0101Aspergillus fumigatus.
a3050Asp r 1Aspergillus restrictus.
m219Asp f 2Aspergillus fumigatus.
m220Asp f 3.0101Aspergillus fumigatus.
m221Asp f 4Aspergillus fumigatus.
m222Asp f 6.0101Aspergillus fumigatus.
m223Staphylococcal enterotoxin C (Sta a SEC)Staphylococcus aureus.
m224Staphylococcal enterotoxin D (Sta a SED)Staphylococcus aureus.
m226Staphylococcal enterotoxin TSST (Sta a TSST)Staphylococcus aureus.
m227Malassezia spp. (Pityrosporum spp.)Malassezia spp. (Pityrosporum spp.).
m228Aspergillus flavus.
m229Alt a 1.0101Alternaria alternata (Alternaria tenuis).
m230Alt a 6.0101Alternaria alternata (Alternaria tenuis).
m231Cla h 8.0101Cladosporium herbarum (Hormodendrum).
m300Eurotium sppEurotium spp.
m304Aspergillus oryzaeAspergillus oryzae.
m305Penicillium brevicompactumPenicillium brevicompactum.
m309Aspergillus terreusAspergillus terreus.
m310Aspergillus nidulansAspergillus nidulans.
m311Aspergillus flavusAspergillus flavus.
m312Aspergillus clavatusAspergillus clavatus.
Epidermal & Animal
e6Guinea pig epitheliumCavia porcellus.
e7Pigeon droppingsColumba palumbus, Columba livia.
e25Chicken serumGallus domesticus (Gallus gallus domesticus; Gallus spp.).
e26Parrot serumPsittacoidea spp.
e62CamelCamelus dromedaries.
e70Goose feathersAnser anser.
e71Mouse epitheliumMus musculus (Mus spp.).
e73Rat epitheliumRattus norvegicus.
e74Rat urine proteinsRattus norvegicus, Rattus rattus.
e75Rat serum proteinsRattus norvegicus, Rattus rattus.
e76Mouse serum proteinsMus musculus (Mus spp.).
e77Budgerigar droppingsMelopsittacus undulatus.
e78Budgerigar feathersMelopsittacus undulatus.
e79Budgerigar serum proteinsMelopsittacus undulatus.
e80Goat epitheliumCapra hircus.
e81Sheep epitheliumOvis aries (Ovis spp.).
e82Rabbit epitheliumOryctolagus cuniculus (Oryctolagus spp.).
e83Swine epitheliumSus scrofa (Sus scrofa domesticus; Sus spp.).
e84Hamster epitheliumCricetus cricetus, Mesocricetus auratus, and Phodopus sungorus.
e85Chicken feathersGallus domesticus (Gallus gallus domesticus; Gallus spp.).
e86Duck feathersAnas platyrhynchos.
e87Rat epithelium, serum proteins, and urine proteinsRattus norvegicus Rattus rattus.
e88Mouse epithelium, serum proteins, and urine proteins (mouse)Mus musculus (Mus spp.).
e89Turkey feathersMeleagris gallopavo.
e90Budgerigar serum proteins, feathers, and droppingsMelopsittacus undulatus.
e91Pigeon serum proteins, feathers, and droppingsStreptopelia roseogrisea, Psittacidae spp.
e92Parrot serum proteins, feathers, and droppingsAra spp.
e93Pigeon serum proteinsStreptopelia roseogrisea.
e94Fel d 1.0101Felis domesticus.
a345Fel d 1Felis domesticus.
e98Parrot droppingsPsittacoidea spp.
e101Can f 1.0101Canis familiaris (Canis domesticus).
a174Can f 1Canis familiaris (Canis domesticus).
e102Can f 2.0101Canis familiaris (Canis domesticus).
e196Parakeet feathersNymphicus hollandicus.
e197Parakeet droppingsNymphicus hollandicus.
e198Parakeet serumNymphicus hollandicus.
e199Canary bird serumSerinus canarius.
e200Canary bird droppingsSerinus canarius.
e201Canary bird feathers (Canary feathers)Serinus canarius.
e202Reindeer epitheliumRangifer tarandus.
e203Mink epitheliumMustela spp.
Start Printed Page 71806
e204Bos d 6Bos domesticus (Bos taurus; Bos spp.).
e205Horse, serum proteinsEquus caballus (Equus spp.).
e206Rabbit, serum proteinsOryctolagus cuniculus (Oryctolagus spp.).
e208Chinchilla epitheliumChinchilla laniger.
e209Gerbil epitheliumMeriones unguiculatus.
e210Fox epitheliumVulpes vulpes.
e211Rabbit, urine proteinsOryctolagus cuniculus (Oryctolagus spp.).
e212Swine, urine proteinsSus scrofa (Sus scrofa domesticus; Sus spp.).
e213Parrot feathersAra spp.
e214Finch feathersLonchura domestica.
e215Pigeon feathersStreptopelia roseogrisea (Streptopelia spp.), Columbia spp.
e216Deer epitheliumDama dama.
e217Ferret epitheliumMustela putorius.
e218Chicken droppingsGallus domesticus (Gallus gallus domesticus; Gallus spp.).
e219Chicken, serum proteinsGallus domesticus (Gallus gallus domesticus; Gallus spp.).
e220Fel d 2, Cat serum albuminFelis domesticus.
e221Can f 3Canis familiaris (Canis domesticus) (Dog serum albumin).
e222Swine serum albumin (Sus s PSA)Sus scrofa (Sus scrofa domesticus; Sus spp.).
e225Lovebird feathersPsittacoidea agapomis.
e226Can f 5.0101Canis familiaris.
e227Equ c 1.0101Equus caballus.
e228Fel d 4.0101Felis domesticus.
e230Equ c 3Equus caballus.
e231Mus m 1Mus musculus.
Food
f9RiceOryza sativa.
f12Pea (green pea)Pisum sativum.
f15White beanPhaseolus vulgaris.
f19Cayenne pepperCapsicum frutescens (Capsicum annum).
f21Sugar caneSaccharum officinarum.
f22RaspberryRubus idaeus.
f26PorkSus scrofa (Sus scrofa domesticus; Sus spp.).
f29WatermelonCitrullus lanatus (Citrullus vulgaris).
f31CarrotDaucus carota.
f32Oyster mushroomPleurotus ostreatus.
f33OrangeCitrus sinensis.
f35PotatoSolanum tuberosum.
f43Mother's milkHomo sapiens.
f44StrawberryFragaria vesca (Fragaria spp.).
f45Yeast, baker'sSaccharomyces cerevisiae.
f46Pepper, RedCapsicum annuum.
f47GarlicAllium sativum.
f48OnionAllium cepa.
f49AppleMalus x domestica (Malus spp.).
f51Bamboo shootPhyllostachys pubescens.
f52Cacao/chocolateTheobroma cacao.
f54Sweet potatoIpomoea batatas.
f55Common milletPanicum miliaceum.
f56Foxtail milletSetaria italica.
f57Japanese milletEchinochloa crus-galli.
f58Pacific squidTodarodes pacificus.
f59OctopusOctopus vulgaris (Octopus spp.).
f63KefirNA.
f67Parmesan cheeseNA.
f81Cheese, cheddar typeNA.
f82Cheese, mold typeNA.
f83ChickenGallus domesticus (Gallus gallus domesticus; Gallus spp.).
f86ParsleyPetroselinum crispum.
f87MelonCucumis melo Cucumis melo + Citrullus lanatus.
f88Mutton (lamb)Ovis aries (Ovis spp.).
f90MaltHordeum vulgare.
f92BananaMusa spp.
f93CacaoTheobroma cacao.
f94PearPyrus communis (Pyrus spp.).
f97YamDioscorea spp. Dioscorea opposita.
f97Chamomile teaMatricaria chamomilla.
f98GliadinTriticum aestivum (Triticum spp.).
f102CantaloupeCucumis melo var. cantalupensis.
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f105ChocolateTheobroma cacao.
f109CottonseedGossypium hirsutum.
f110Giant radishRaphanus sativus.
f118ZucchiniCucurbita pepo.
f119RadishRaphanus sativus.
f120VenisonCapreolus capeolus.
f121Pinto beanPhaseolus vulgaris.
f122Cheese, AmericanNA.
f127Black-eyed peaVigna unguiculata.
f131Black OliveOlea europaea.
f136Red beetBeta vulgaris var. conditiva.
f139Goat's CheeseCapra aegagrus.
f140BranNA.
f141Corn (vegetables)Zea mays.
f152Green bell pepperCapsicum annuum.
f155Brewer's yeastSaccharomyces carlsbergensis.
f157DuckAnas domesticus.
f158GooseAnser anser.
f160Camembert cheeseNA.
f162NectarinePrunus persica var. nucipersica.
f163KohlrabiBrassica oleracea var. gongylodes.
f65Perch
f166LeekAllium porrum.
f170Cheese (Switzerland) (Swiss cheese)NA.
f174FigFicus carica.
f177CranberryVaccinium macrocarpon.
f179RaisinVitis spp.
f182Lima beanPhaseolus lunatus.
f198Flaxseed (bruised grain)Linum usitatissimum.
f199Untreated native milkBos domesticus (Bos taurus; Bos spp.).
f208LemonCitrus limon.
f209GrapefruitCitrus paradisi.
f210PineappleAnanas comosus.
f211BlackberryRubus fruticosus.
f212Mushroom (champignon)Agaricus hortensis (Agaricus spp.).
f213RabbitOryctolagus cuniculus (Oryctolagus spp.).
f214SpinachSpinacia oleracea.
f215LettuceLactuca sativa.
f216CabbageBrassica oleracea var. capitata.
f217Brussels sproutsBrassica oleracea var. gem.
f218Paprika, sweet pepperCapsicum annuum.
f219Fennel seedFoeniculum vulgare.
f219SageSalvia officinalis.
f220CinnamonCinnamomum spp.
f221CoffeeCoffea spp.
f222TeaCamellia sinensis.
f223Green oliveOlea europaea.
f225Summer squash, pumpkinCucurbita pepo.
f225PumpkinCucurbita maxima.
f226Pumpkin seedCucurbita pepo.
f227Sugar-beet seedBeta vulgaris.
f229Safflower SeedCarthamus tinctorius.
f231Milk, boiledBos domesticus (Bos taurus; Bos spp.).
f234VanillaVanilla planifolia.
f237ApricotPrunus armeniaca.
f241Gouda cheeseNA.
f242CherryPrunus avium.
f244CucumberCucumis sativus.
f246Guar, guar gumCyamopsis tetragonoloba.
f247HoneyNA.
f248RosemaryRosmarinus officinalis.
f254PlaicePleuronectes platessa.
f255PlumPrunus domestica, Prunus americana.
f258SquidLoligo spp.
f259GrapeVitis vinifera (Vitis spp.).
f260BroccoliBrassica oleracea var. italica (Brassica oleracea var. cultivar).
f261AsparagusAsparagus officinalis.
f262Aubergine, eggplantSolanum melongena.
f263Green pepperPiper nigrum, Capsicum annuum.
Start Printed Page 71808
f264EelAnguilla anguilla.
f265CarawayCarum carvi.
f265CuminCuminum cyminum.
f266MaceMyristica fragrans.
f267CardamonElettaria cardamomum.
f268CloveSyzygium aromaticum.
f269BasilOcimum basilicum.
f270GingerZingiber officinale.
f271AnisePimpinella anisum.
f272TarragonArtemisia dracunculus.
f273ThymeThymus vulgaris.
f274MarjoramOriganum majorana.
f275LovageLevisticum officinale.
f276Fennel, freshFoeniculum vulgare.
f277DillAnethum graveolens.
f278Bay leafLaurus nobilis.
f279Chili pepperCapsicum frutescens.
f280Black pepperPiper nigrum.
f281Curry (Santa Maria)NA.
f282NutmegMyristica fragrans.
f283OreganoOriganum vulgare.
f284Turkey meatMeleagris gallopavo.
f285Elk/moose meatAlces spp.
f286Mare's milkEquus caballus (Equus spp.).
f287Red kidney beanPhaseolus vulgaris.
f288BlueberryVaccinium myrtillus (Vaccinium spp.).
f289DatePhoenix dactylifera.
f291CauliflowerBrassica oleracea var. botrytis.
f292GuavaPsidium guajava.
f293PapayaCarica papaya.
f294Passion fruit, MaracujaPassiflora edulis (Passiflora spp.).
f295CarambolaAverrhoa carambola.
f296CarobCeratonia siliqua.
f297Gum ArabicAcacia senegal (Acacia spp.).
f298TragacanthAstragalus spp.
f299Sweet chestnut (chestnut)Castanea sativa.
f300Pinto beanPhaseolus spp.
f301Persimmon (kaki fruit, sharon)Diospyros kaki.
f302Mandarin (tangerine, clementine, satsumas)Citrus reticulata.
f305FenugreekTrigonella foenum-graecum.
f306LimeCitrus aurantifolia.
f307HakeMerluccius merluccius.
f308Sardine (pilchard)Sardina pilchardus.
f310Blue vetchLathyrus sativus.
f311MegrimLepidorhombus whiffiagonis.
f315Green beanPhaseolus vulgaris.
f316Rape seedBrassica napus.
f317CorianderCoriandrum sativum.
f318Jack fruitArtocarpus heterophyllus.
f319BeetrootBeta vulgaris.
f320CrayfishAstacus astacus.
f321Horse meatEquus caballus (Equus spp.).
f322Red currantRibes sylvestre.
f324Hop (fruit cone)Humulus lupulus.
f325SaffronColchicum autumnale.
f328FigFicus carica.
f329WatermelonCitrullus lanatus.
f330Rose hipRosa spp.
f331SaffronCrocus sativus.
f332MintMentha piperita.
f333LinseedLinum usitatissimum.
f336JujubeZiziphus jujuba.
f336Wine vinegarVitis vinifera (Vitis spp.).
f337SoleSolea solea.
f337English soleParophrys vetulus.
f338Wine, whiteVitis vinifera (Vitis spp.).
f339AllspicePimenta dioica.
f339Wine, redVitis vinifera (Vitis spp.).
f341CranberryVaccinium oxycoccus, Vaccinium macrocarpon.
f342Olive (black, fresh)Olea europaea.
Start Printed Page 71809
f343RaspberryRubus idaeus.
f344SageSalvia officinalis.
f346ChivesAllium schoenoprasum.
f347QuinoaChenopodium quinoa.
f348LitchiLitchi chinensis.
f349Chum salmon roeOncorhynchus keta.
f358ArtichokeCynara scolymus.
f360YogurtNA.
f368Black bassMicropterus dolomieu (Micropterus dolomieui).
f374Karaya gumSterculia urens.
f375HorseradishArmoracia rusticana.
f377Maple syrupNA.
f379OkraAbelmoschus esculentus.
f382Beet, sugarBeta vulgaris var. altissima.
f401LoquatEriobotrya japonica.
f402FigFicus carica.
f403Brewer's yeastSaccharomyces cerevisiae.
f405MintMentha spp.
f406ArugulaEruca vesicaria.
House Dust
h1Greer Labs., IncNA.
h2Hollister-Stier LabsNA.
h6JapanNA.
Venoms & Insects
i7MidgeChironomus yoshimatsui.
i8MothBombyx mori, Heterocera spp.
i47Water fleaDaphnia spp.
i49Deer flyChrysops spp.
i51Black antCamponotus pennsylvanicus.
i54Flea mix (dog/cat), common fleaCtenocephalides spp.
i71MosquitoAedes communis, Aedes spp. and Culex spp.
i72Green nimittiCladotanytarsus lewisi.
i73Blood wormChironomus thummi, Chironomusri parius, Chironomus spp.
i75European hornetVespa crabro.
i76Berlin beetleTrogoderma angustum.
i77European paper waspPolistes dominulus.
i78FlyMusca domestica.
i80BumblebeeBombus pennsylvanicus.
i201Horse bot flyGasterophilus intestinalis.
i202Grain weevilSitophilus granarius.
i203Mediterranean flour mothEphestia kuehniella (Anagasta kuehniella).
i204Horse flyTabanus spp.
i205BumblebeeBombus terrestris.
i208Api m 1.0101Apis mellifera.
a45Api m 1Apis mellifera.
i209Ves v 5.0101Vespula vulgaris.
a670Ves v 5Vespula vulgaris.
i210Pol d 5.0101Polistes dominulus.
i211Ves v 1.0101Vespula vulgaris.
i213Api m 4Apis mellifera.
i214Api m 2Apis mellifera.
i215Api m 3Apis mellifera.
i216Api m 5Apis mellifera.
i217Api m 10Apis mellifera.
i220Bla g 1.0101Blattella germanica.
i221Bla g 2.0101Blattella germanica.
i222Bla g 5.0101Blattella germanica.
i223Bla g 7Blattella germanica.
a46Api m 2Apis mellifera.
Miscellaneous
o1Cotton, crude fibersGossypium spp.
o3Cotton (treated)Gossypium spp.
o70Seminal fluidHomo sapiens.
o71Staphylococcus aureusStaphylococcus aureus.
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o72Pichia pastoris crude extract customer specificPichia pastoris.
o72Sperm-sedimentHomo sapiens.
o73Pichia pastoris crude extr. vector customer specificPichia pastoris.
o74Pichia pastoris with vector customer specificPichia pastoris.
o201Tobacco leaf, tobacco dustNicotiana tabacum.
o202Artemia salina, fish feedArtemia salina.
o203Tetramin, fish feedNA.
o207Daphnia, fish feedDaphnia spp.
o211MealwormTenebrio molitor.
o212StreptavidinStreptomyces avidini.
o213MBP (maltose binding protein)Escherichia coli.
o214CCD; MUXF3 from bromelainAnanas comosus.
o72Enterotoxin A (Sta a SEA)Staphylococcus aureus.
o73Enterotoxin B (Sta a SEB)Staphylococcus aureus.
Parasites
p1AscarisAscaris suum.
p2EchinococcusEchinococcus granulosus.
p3SchistosomaSchistosoma mansoni.
p4Anisakis (Herring Worm)Anisakis simplex (Anisakis spp.).
p5Toxocara canisToxocara canis.
p10Ani s 3.0101Anisakis simplex (Anisakis spp.).
p11Ani s 1Anisakis simplex (Anisakis spp.).
Occupational
k4Threshing dustNA.
k5FlaxNA.
k7Hay DustNA.
k8Hop (hops)Humulus lupulus.
k12Grain mill dustNA.
k14KapokNA.
k20Sheep's wool (treated) (wool)Ovis aries (Ovis spp.).
k21Sheep's wool (Untreated)Ovis aries (Ovis spp.).
k23Straw DustNA.
k33OakNA.
k70Green coffee beanCoffea spp.
k71Castor beanRicinus communis.
k72IspaghulaPlantago psyllium/Plantago ovata.
k73Silk wasteNA.
k74SilkBombyx mori.
k75Isocyanate TDI (Toluene diisocyanate)NA.
k76Isocyanate MDI (Diphenylmethane diisocyanate)NA.
k77Isocyanate HDI (Hexamethylen diisocyanate)NA.
k78Ethylene oxideNA.
k79Phthalic anhydrideNA.
k80Formaldehyde/FormalinNA.
k81FicusFicus benjamina (Ficus spp.).
k83Cotton seedGossypium hirsutum.
k84Sunflower seedHelianthus annuus.
k85Chloramin TNA.
k86Trimellitic anhydride, TMANA.
k87Asp o 21, alpha-amylaseAspergillus oryzae.
k89Orris rootIris florentina.
k99HSA (Human Serum Albumin) (Hom s HSA)Homo sapiens.
k201Car p 1, PapainCarica papaya.
k202Ana c 2, BromelainAnanas comosus.
k204MaxataseBacillus licheniformis.
k205AlcalaseBacillus spp.
k206Savinase, Protease 1 (Bac l Subtilisin)Bacillus spp.
k208Gal d 4, LysozymeGallus domesticus (Gallus gallus domesticus; Gallus spp.).
k209Hexahydrophtalic anhydridNA.
k210Maleic anhydrideNA.
k211Methyltetrahydrophtalic anhydridNA.
k212Abachi wood dustTriplochiton scleroxylon.
k213Pepsin (Sus s Pepsin)Sus scrofa (Sus scrofa domesticus; Sus spp.).
k213TCPANA.
k214BougainvilleaBougainvillea spp.
k225Horse radish peroxidase (Arm r HRP)Armoracia rusticana.
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k226Ascorbate oxidase (Cuc p ascorbate oxidase)Cucurbita pepo.
k301Flour dustTriticum spp.
k501Savinase customer specificProprietary knowledge of customer.
k502Lipolase customer specificProprietary knowledge of customer.
k503Termamyl customer specificProprietary knowledge of customer.
k504Clazinase customer specificProprietary knowledge of customer.
Start Amendment Part

66. In § 866.5910, revise paragraph (b) to read as follows:

End Amendment Part
Quality control material for cystic fibrosis nucleic acid assays.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays.” See § 866.1(e) for the availability of this guidance document.

Start Part

PART 868—ANESTHESIOLOGY DEVICES

End Part Start Amendment Part

67. The authority citation for part 868 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

End Authority Start Amendment Part

68. In § 868.1040, revise paragraph (b) to read as follows:

End Amendment Part
Powered algesimeter.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

Start Amendment Part

69. In § 868.2385, revise paragraph (b) to read as follows:

End Amendment Part
Nitrogen dioxide analyzer.
* * * * *

(b) Classification. Class II (special controls). The device, when it is a standalone nitrogen dioxide analyzer and not those that are components of nitric oxide delivery systems intended to monitor nitrogen dioxide levels during inhaled nitric oxide therapy, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. The special control is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.” See § 868.1(e) for the availability of this guidance document.

Start Amendment Part

70. In § 868.2500, revise paragraph (b) to read as follows:

End Amendment Part
Cutaneous oxygen (PcO2) monitor.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. The special control is FDA's “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA.” See § 868.1(e) for the availability of this guidance document.

Start Amendment Part

71. In § 868.2550, revise paragraph (b) to read as follows:

End Amendment Part
Pneumotachometer.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

Start Amendment Part

72. In § 868.5180, revise paragraph (b) to read as follows:

End Amendment Part
Rocking bed.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

Start Amendment Part

73. In § 868.6250, revise paragraph (b) to read as follows:

End Amendment Part
Portable air compressor.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

Start Part

PART 870—CARDIOVASCULAR DEVICES

End Part Start Amendment Part

74. The authority citation for part 870 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

End Authority Start Amendment Part

75. In § 870.1330, revise paragraph (b) to read as follows:

End Amendment Part
Catheter guide wire.
* * * * *

(b) Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Start Amendment Part

76. In § 870.1390, revise paragraph (b) to read as follows:

End Amendment Part
Trocar.
* * * * *

(b) Classification. Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Start Amendment Part

77. In § 870.1650, revise paragraph (b) to read as follows:

End Amendment Part
Angiographic injector and syringe.
* * * * *

(b) Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Start Amendment Part

78. In § 870.1875, revise paragraph (b)(2) to read as follows:

End Amendment Part
Stethoscope.
* * * * *

(b) * * *

(2) Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Start Printed Page 71812 Start Amendment Part

79. In § 870.2675, revise paragraph (b) to read as follows:

End Amendment Part
Oscillometer.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Start Amendment Part

80. In § 870.2770, revise paragraph (b) to read as follows:

End Amendment Part
Impedance plethysmograph.
* * * * *

(b) Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Start Amendment Part

81. In § 870.4280, revise paragraph (b) to read as follows:

End Amendment Part
Cardiopulmonary prebypass filter.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Start Amendment Part

82. In § 870.4290, revise paragraph (b) to read as follows:

End Amendment Part
Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Start Amendment Part

83. In § 870.4340, revise paragraph (b) to read as follows:

End Amendment Part
Cardiopulmonary bypass level sensing monitor and/or control.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Start Amendment Part

84. In § 870.4400, revise paragraph (b) to read as follows:

End Amendment Part
Cardiopulmonary bypass blood reservoir.
* * * * *

(b) Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Start Amendment Part

85. In § 870.4420, revise paragraph (b) to read as follows:

End Amendment Part
Cardiopulmonary bypass cardiotomy return sucker.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Start Amendment Part

86. In § 870.4430, revise paragraph (b) to read as follows:

End Amendment Part
Cardiopulmonary bypass intracardiac suction control.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Start Part

PART 872—DENTAL DEVICES

End Part Start Amendment Part

87. The authority citation for part 872 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

End Authority Start Amendment Part

88. In § 872.1720, revise paragraph (b) to read as follows:

End Amendment Part
Pulp tester.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

Start Amendment Part

89. In § 872.3260, revise paragraph (b) to read as follows:

End Amendment Part
Cavity varnish.
* * * * *

(b) Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

Start Amendment Part

90. In § 872.3300, revise paragraph (b) to read as follows:

End Amendment Part
Hydrophilic resin coating for dentures.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

Start Amendment Part

91. In § 872.3540, revise paragraph (b)(2) introductory text to read as follows:

End Amendment Part
OTC denture cushion or pad.
* * * * *

(b) * * *

(2) Class II (special controls) if the OTC denture cushion or pad is made of a material other than wax-impregnated cotton cloth or if the intended use of the device differs from that described in paragraph (b)(1) of this section. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. The special controls for this device are FDA's:

* * * * *
Start Amendment Part

92. In § 872.3560, revise paragraph (b) introductory text to read as follows:

End Amendment Part
OTC denture reliner.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. The special controls for this device are FDA's:

* * * * *
Start Amendment Part

93. In § 872.3590, revise paragraph (b) to read as follows:

End Amendment Part
Preformed plastic denture tooth.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

Start Amendment Part

94. In § 872.3600, revise paragraph (b) introductory text to read as follows:

End Amendment Part
Partially fabricated denture kit.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. The special controls for this device are FDA's:

* * * * *
Start Amendment Part

95. In § 872.3890, revise paragraph (b) to read as follows:

End Amendment Part
Endodontic stabilizing splint.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

Start Amendment Part

96. In § 872.5550, revise paragraph (b)(2) to read as follows:

End Amendment Part
Teething ring.
* * * * *

(b) * * * Start Printed Page 71813

(2) Class II (special controls) if the teething ring contains a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

Start Amendment Part

97. In § 872.6770, revise paragraph (b) to read as follows:

End Amendment Part
Cartridge syringe.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

Start Part

PART 874—EAR, NOSE, AND THROAT DEVICES

End Part Start Amendment Part

98. The authority citation for part 874 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

End Authority Start Amendment Part

99. In § 874.1090, revise paragraph (b) to read as follows:

End Amendment Part
Auditory impedance tester.
* * * * *

(b) Classification. Class II (special controls). The device, when it is a tympanometer or auditory impedance tester that complies with FDA-recognized consensus standard ANSI S3.39, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

Start Amendment Part

100. In § 874.1120, revise paragraph (b) to read as follows:

End Amendment Part
Electronic noise generator for audiometric testing.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

Start Amendment Part

101. In § 874.1325, revise paragraph (b) to read as follows:

End Amendment Part
Electroglottograph.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

Start Amendment Part

102. In § 874.3310, revise paragraph (b) to read as follows:

End Amendment Part
Hearing aid calibrator and analysis system.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

Start Amendment Part

103. In § 874.3320, revise paragraph (b) to read as follows:

End Amendment Part
Group hearing aid or group auditory trainer.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

Start Amendment Part

104. In § 874.3330, revise paragraph (b) to read as follows:

End Amendment Part
Master hearing aid.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

Start Amendment Part

105. In § 874.3430, revise paragraph (b) to read as follows:

End Amendment Part
Middle ear mold.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

Start Amendment Part

106. In § 874.3730, revise paragraph (b) to read as follows:

End Amendment Part
Laryngeal prosthesis (Taub design).
* * * * *

(b) Classification. Class II (special controls). The device, when it is a voice amplification device, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

Start Part

PART 876—GASTROENTEROLOGY-UROLOGY DEVICES

End Part Start Amendment Part

107. The authority citation for part 876 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

End Authority Start Amendment Part

108. In § 876.1500, revise paragraph (b)(1) to read as follows:

End Amendment Part
Endoscope and accessories.
* * * * *

(b) * * *

(1) Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

* * * * *
Start Amendment Part

109. In § 876.4020, revise paragraph (b) to read as follows:

End Amendment Part
Fiberoptic light ureteral catheter.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Start Amendment Part

110. In § 876.4270, revise paragraph (b) to read as follows:

End Amendment Part
Colostomy rod.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Start Amendment Part

111. In § 876.4400, revise paragraph (b) to read as follows:

End Amendment Part
Hemorrhoidal ligator.
* * * * *

(b) Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Start Amendment Part

112. In § 876.4500, revise paragraph (b) to read as follows:

End Amendment Part
Mechanical lithotriptor.
* * * * *

(b) Classification. Class II (special controls). The device, when it is a biliary mechanical lithotripter, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Start Amendment Part

113. In § 876.4770, revise paragraph (b) to read as follows:

End Amendment Part
Urethrotome.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Start Printed Page 71814 Start Amendment Part

114. In § 876.5010, revise paragraph (b) to read as follows:

End Amendment Part
Biliary catheter and accessories.
* * * * *

(b) Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Start Amendment Part

115. In § 876.5025, revise paragraph (b) introductory text to read as follows:

End Amendment Part
Vibrator for climax control of premature ejaculation.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. The special controls for this device are:

* * * * *
Start Amendment Part

116. In § 876.5160, revise the section heading and paragraph (b) to read as follows:

End Amendment Part
Urological clamp.
* * * * *

(b) Classification. Class I (general controls). Except when intended for internal use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Start Amendment Part

117. In § 876.5365, revise paragraph (b) to read as follows:

End Amendment Part
Esophageal dilator.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Start Amendment Part

118. In § 876.5520, revise paragraph (b)(1) to read as follows:

End Amendment Part
Urethral dilator.
* * * * *

(b) * * *

(1) Class II (special controls). Except when it is a mechanical urethral dilator, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

* * * * *
Start Amendment Part

119. In § 876.5630, revise paragraph (b) to read as follows:

End Amendment Part
Peritoneal dialysis system and accessories.
* * * * *

(b) Classification. Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.

Start Amendment Part

120. In § 876.5665, revise paragraph (b) to read as follows:

End Amendment Part
Water purification system for hemodialysis.
* * * * *

(b) Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Start Amendment Part

121. In § 876.5895, revise paragraph (b) to read as follows:

End Amendment Part
Ostomy irrigator.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Start Amendment Part

122. In § 876.5980, revise paragraph (b)(1) to read as follows:

End Amendment Part
Gastrointestinal tube and accessories.
* * * * *

(b) * * *

(1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

* * * * *
Start Part

PART 878—GENERAL AND PLASTIC SURGERY DEVICES

End Part Start Amendment Part

123. The authority citation for part 878 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

End Authority Start Amendment Part

124. In § 878.4370, revise paragraph (b) to read as follows:

End Amendment Part
Surgical drape and drape accessories.
* * * * *

(b) Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Start Amendment Part

125. In § 878.4495, revise paragraph (b) to read as follows:

End Amendment Part
Stainless steel suture.
* * * * *

(b) Classification. Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Start Amendment Part

126. In § 878.4580, revise paragraph (b) to read as follows:

End Amendment Part
Surgical lamp.
* * * * *

(b) Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Start Amendment Part

127. In § 878.5070, revise paragraph (b) to read as follows:

End Amendment Part
Air-handling apparatus for a surgical operating room.
* * * * *

(b) Classification. Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Start Part

PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES

End Part Start Amendment Part

128. The authority citation for part 880 continues to read as follows:

End Amendment Part Start Authority

Start Printed Page 71815 Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

End Authority Start Amendment Part

129. In § 880.5580, revise paragraph (b) introductory text to read as follows:

End Amendment Part
Acupuncture needle.
* * * * *

(b) Classification. Class II (special controls). The device, when it is an acupuncture point locator or a single use acupuncture needle, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. Acupuncture needles must comply with the following special controls:

* * * * *
Start Amendment Part

130. In § 880.5680, revise paragraph (b) to read as follows:

End Amendment Part
Pediatric position holder.
* * * * *

(b) Classification. Class I (general controls). Except when the device is an infant positioner for prescription use in highly monitored settings or an infant sleep position holder, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. The device is exempt from the good manufacturing practice regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

Start Amendment Part

131. In § 880.5780, revise paragraph (a)(2) to read as follows:

End Amendment Part
Medical support stocking.

(a) * * *

(2) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

* * * * *
Start Amendment Part

132. In § 880.6250, revise paragraph (b) to read as follows:

End Amendment Part
Non-powdered patient examination glove.
* * * * *

(b) Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

Start Amendment Part

133. In § 880.6375, revise paragraph (b) to read as follows:

End Amendment Part
Patient lubricant.
* * * * *

(b) Classification. Class I (general controls). Except when the device is a vaginal patient lubricant or an oral lubricant, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

Start Amendment Part

134. In § 880.6760, revise paragraph (b) to read as follows:

End Amendment Part
Protective restraint.
* * * * *

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

Start Part

PART 882—NEUROLOGICAL DEVICES

End Part Start Amendment Part

135. The authority citation for part 882 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

End Authority Start Amendment Part

136. In § 882.1020, revise paragraph (b) to read as follows:

End Amendment Part
Rigidity analyzer.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

Start Amendment Part

137. In § 882.1030, revise paragraph (b) to read as follows:

End Amendment Part
Ataxiagraph.
* * * * *

(b) Classification. Class I (general controls). Except when the device is intended to provide an interpretation or a clinical implication of the measurement, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

Start Amendment Part

138. In § 882.1470, revise paragraph (b) introductory text to read as follows:

End Amendment Part
Computerized cognitive assessment aid.
* * * * *

(b) Classification. Class II (special controls). Except when the computerized cognitive assessment aid is intended for diagnostic assessment of specific diseases or conditions and relies on inputs from visual cues, auditory cues, and/or functional use of the hand, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9. The special control(s) for this device are:

* * * * *
Start Amendment Part

139. In § 882.1540, revise paragraph (b) to read as follows:

End Amendment Part
Galvanic skin response measurement device.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

Start Amendment Part

140. In § 882.1560, revise paragraph (b) to read as follows:

End Amendment Part
Skin potential measurement device.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

Start Amendment Part

141. In § 882.1855, revise paragraph (b) to read as follows:

End Amendment Part
Electroencephalogram (EEG) telemetry system.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

Start Amendment Part

142. In § 882.4060, revise paragraph (b) to read as follows:

End Amendment Part
Ventricular cannula.
* * * * *

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

Start Amendment Part

143. In § 882.4545, revise paragraph (b) to read as follows:

End Amendment Part
Shunt system implantation instrument.
* * * * *

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

Start Amendment Part

144. In § 882.5895, revise paragraph (b) introductory text to read as follows:

End Amendment Part
Vibratory counter-stimulation device.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9. The special controls for this device are:

* * * * *
Start Part

PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES

End Part Start Amendment Part

145. The authority citation for part 884 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

End Authority Start Printed Page 71816 Start Amendment Part

146. In § 884.1630, revise paragraph (b) to read as follows:

End Amendment Part
Colposcope.
* * * * *

(b) Classification. Class II (special controls). The device, when it is a standard colposcope (or colpomicroscope) that uses only a white light source, does not use filters other than a green filter, does not include image analysis software, and is not smartphone-based, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

Start Amendment Part

147. In § 884.2990, revise paragraph (b) to read as follows:

End Amendment Part
Breast lesion documentation system.
* * * * *

(b) Classification. Class II (special controls). The device, when it is a breast examination recording sheet, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Breast Lesion Documentation System.” See § 884.1(e) for the availability of this guidance document.

Start Amendment Part

148. In § 884.3200, revise paragraph (b) to read as follows:

End Amendment Part
Cervical drain.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

Start Amendment Part

149. In § 884.4400, revise paragraph (b) to read as follows:

End Amendment Part
Obstetric forceps.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

Start Amendment Part

150. In § 884.4530, revise paragraph (b)(1) to read as follows:

End Amendment Part
Obstetric-gynecologic specialized manual instrument.
* * * * *

(b) * * *

(1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

* * * * *
Start Amendment Part

151. In § 884.4900, revise paragraph (b) to read as follows:

End Amendment Part
Obstetric table and accessories.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

Start Amendment Part

152. In § 884.5200, revise paragraph (b) introductory text to read as follows:

End Amendment Part
Hemorrhoid prevention pressure wedge.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. The special controls for this device are:

* * * * *
Start Amendment Part

153. In § 884.5390, revise paragraph (b) to read as follows:

End Amendment Part
Perineal heater.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

Start Amendment Part

154. In § 884.5400, revise paragraph (b) to read as follows:

End Amendment Part
Menstrual cup.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

Start Amendment Part

155. In § 884.5425, revise paragraph (b)(2) to read as follows:

End Amendment Part
Scented or scented deodorized menstrual pad.
* * * * *

(b) * * *

(2) Class II (special controls) for scented or scented deodorized menstrual pads made of materials not described in paragraph (b)(1). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

Start Amendment Part

156. In § 884.5435, revise paragraph (b) to read as follows:

End Amendment Part
Unscented menstrual pad.
* * * * *

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9 only when the device is made of common cellulosic and synthetic material with an established safety profile.

Start Amendment Part

157. In § 884.6120, revise paragraph (b) to read as follows:

End Amendment Part
Assisted reproduction accessories.
* * * * *

(b) Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device, when it is a simple embryo incubator with only temperature, gas, and humidity control; a syringe pump; a collection tube warmer; a dish/plate/microscope stage warmer; or a controlled-rate cryopreservation freezer, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

Start Amendment Part

158. In § 884.6130, revise paragraph (b) to read as follows:

End Amendment Part
Assisted reproduction microtools.
* * * * *

(b) Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when the assisted reproduction microtools (pipettes) are manufactured from glass, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

Start Amendment Part

159. In § 884.6150, revise paragraph (b) to read as follows:

End Amendment Part
Assisted reproduction micromanipulators and microinjectors.
* * * * *

(b) Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

Start Amendment Part

160. In § 884.6160, revise paragraph (b) to read as follows:

End Amendment Part
Assisted reproduction labware.
* * * * *

(b) Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when Start Printed Page 71817it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

Start Part

PART 886—OPHTHALMIC DEVICES

End Part Start Amendment Part

161. The authority citation for part 886 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

End Authority Start Amendment Part

162. In § 886.1120, revise paragraph (b) to read as follows:

End Amendment Part
Ophthalmic camera.
* * * * *

(b) Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Start Amendment Part

163. In § 886.1250, revise paragraph (b) to read as follows:

End Amendment Part
Euthyscope.
* * * * *

(b) Classification. (1) Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

(2) Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Start Amendment Part

164. In § 886.1570, revise paragraph (b) to read as follows:

End Amendment Part
Ophthalmoscope.
* * * * *

(b) Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Start Amendment Part

165. In § 886.1780, revise paragraph (b)(1) to read as follows:

End Amendment Part
Retinoscope.
* * * * *

(b) * * *

(1) Class II (special controls) for the AC-powered device. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

* * * * *
Start Amendment Part

166. In § 886.1850, revise paragraph (b) to read as follows:

End Amendment Part
AC-powered slitlamp biomicroscope.
* * * * *

(b) Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Start Amendment Part

167. In § 886.1945, revise paragraph (b) to read as follows:

End Amendment Part
Transilluminator.
* * * * *

(b) Classification. (1) Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

(2) Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Start Amendment Part

168. In § 886.3320, revise paragraph (b) to read as follows:

End Amendment Part
Eye sphere implant.
* * * * *

(b) Classification. Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Start Amendment Part

169. In § 886.4070, revise paragraph (b) to read as follows:

End Amendment Part
Powered corneal burr.
* * * * *

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Start Amendment Part

170. In § 886.4150, revise paragraph (b) to read as follows:

End Amendment Part
Vitreous aspiration and cutting instrument.
* * * * *

(b) Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Start Amendment Part

171. In § 886.4250, revise paragraph (b) to read as follows:

End Amendment Part
Ophthalmic electrolysis unit.
* * * * *

(b) Classification. (1) Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

(2) Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Start Amendment Part

172. In § 886.4335, revise paragraph (b) to read as follows:

End Amendment Part
Operating headlamp.
* * * * *

(b) Classification. (1) Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

(2) Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Start Amendment Part

173. In § 886.4400, revise paragraph (b) to read as follows:

End Amendment Part
Electronic metal locator.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Start Amendment Part

174. In § 886.4440, revise paragraph (b) to read as follows:

End Amendment Part
AC-powered magnet.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Start Amendment Part

175. In § 886.4790, revise paragraph (b) to read as follows:

End Amendment Part
Ophthalmic sponge.
* * * * *
Start Printed Page 71818

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Start Part

PART 888—ORTHOPEDIC DEVICES

End Part Start Amendment Part

176. The authority citation for part 888 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

End Authority Start Amendment Part

177. In § 888.1240, revise paragraph (b) to read as follows:

End Amendment Part
AC-powered dynamometer.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9.

Start Amendment Part

178. In § 888.4580, revise paragraph (b) to read as follows:

End Amendment Part
Sonic surgical instrument and accessories/attachments.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9.

Start Part

PART 890—PHYSICAL MEDICINE DEVICES

End Part Start Amendment Part

179. The authority citation for part 890 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

End Authority Start Amendment Part

180. In § 890.1450, revise paragraph (b) to read as follows:

End Amendment Part
Powered reflex hammer.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Start Amendment Part

181. In § 890.5100, revise paragraph (b) to read as follows:

End Amendment Part
Immersion hydrobath.
* * * * *

(b) Classification. Class II (special controls). The device, when it is a hydromassage bath or a powered sitz bath, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Start Amendment Part

182. In § 890.5110, revise paragraph (b) to read as follows:

End Amendment Part
Paraffin bath.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Start Amendment Part

183. In § 890.5250, revise paragraph (b) to read as follows:

End Amendment Part
Moist steam cabinet.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Start Amendment Part

184. In § 890.5360, revise paragraph (b) to read as follows:

End Amendment Part
Measuring exercise equipment.
* * * * *

(b) Classification. Class II (special controls). The device, when it is a measuring exerciser, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Start Amendment Part

185. In § 890.5500, revise paragraph (b) to read as follows:

End Amendment Part
Infrared lamp.
* * * * *

(b) Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Start Amendment Part

186. In § 890.5575, revise paragraph (b) to read as follows:

End Amendment Part
Powered external limb overload warning device.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Start Part

PART 892—RADIOLOGY DEVICES

End Part Start Amendment Part

187. The authority citation for part 892 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

End Authority Start Amendment Part

188. In § 892.1000, revise paragraph (b) to read as follows:

End Amendment Part
Magnetic resonance diagnostic device.
* * * * *

(b) Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Start Amendment Part

189. In § 892.1560, revise paragraph (b) to read as follows:

End Amendment Part
Ultrasonic pulsed echo imaging system.
* * * * *

(b) Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Start Amendment Part

190. In § 892.1610, revise paragraph (b) to read as follows:

End Amendment Part
Diagnostic x-ray beam-limiting device.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Start Amendment Part

191. In § 892.1650, revise paragraph (b) to read as follows:

End Amendment Part
Image-intensified fluoroscopic x-ray system.
* * * * *

(b) Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Start Amendment Part

192. In § 892.1670, revise paragraph (b) to read as follows:

End Amendment Part
Spot-film device.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Start Amendment Part

193. In § 892.1680, revise paragraph (b) to read as follows:

End Amendment Part
Stationary x-ray system.
* * * * *

(b) Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of Start Printed Page 71819part 807 of this chapter subject to the limitations in § 892.9.

Start Amendment Part

194. In § 892.1730, revise paragraph (b) to read as follows:

End Amendment Part
Photofluorographic x-ray system.
* * * * *

(b) Classification. Class II (special controls). A discography kit intended for use with a photofluorographic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Start Amendment Part

195. In § 892.1820, revise paragraph (b) to read as follows:

End Amendment Part
Pneumoencephalographic chair.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Start Amendment Part

196. In § 892.1850, revise paragraph (b) to read as follows:

End Amendment Part
Radiographic film cassette.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Start Amendment Part

197. In § 892.1860, revise paragraph (b) to read as follows:

End Amendment Part
Radiographic film/cassette changer.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Start Amendment Part

198. In § 892.1870, revise paragraph (b) to read as follows:

End Amendment Part
Radiographic film/cassette changer programmer.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Start Amendment Part

199. In § 892.1900, revise paragraph (b) to read as follows:

End Amendment Part
Automatic radiographic film processor.
* * * * *

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Start Amendment Part

200. In § 892.2030, revise paragraph (b) to read as follows:

End Amendment Part
Medical image digitizer.
* * * * *

(b) Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Start Amendment Part

201. In § 892.2040, revise paragraph (b) to read as follows:

End Amendment Part
Medical image hardcopy device.
* * * * *

(b) Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Start Amendment Part

202. In § 892.5730, revise paragraph (b) to read as follows:

End Amendment Part
Radionuclide brachytherapy source.
* * * * *

(b) Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Start Signature

Dated: December 13, 2019.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

End Signature End Supplemental Information

Footnotes

1.  FDA notes that the “ACTION” caption for this final order is styled as “Final amendment; final order,” rather than “Final order.” Beginning in December 2019, this editorial change was made to indicate that the document “amends” the Code of Federal Regulations. The change was made in accordance with the Office of Federal Register's (OFR) interpretations of the Federal Register Act (44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and parts 21 and 22), and the Document Drafting Handbook.

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[FR Doc. 2019-27394 Filed 12-27-19; 8:45 am]

BILLING CODE 4164-01-P