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Rule

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

A Rule by the Food and Drug Administration on 12/30/2019

Published Document: 2019-27394 (84 FR 71794)

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Department of Health and Human Services
Food and Drug Administration
  1. 21 CFR Parts 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888, 890, and 892
  2. [Docket Nos. FDA-2017-N-1129 and FDA-2017-N-1610]

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.

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: .

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. ( printed page 71795) FDA 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 ( printed page 71796) the 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.

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

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:

PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

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

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

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

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.

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

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.

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

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.

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

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.

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

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.

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

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:

* * * * *

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

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.

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

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.

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

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.

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

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.

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

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.

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

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 ( printed page 71797) exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

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

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.

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

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.

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

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.

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

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:

* * * * *

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

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.

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

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.

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

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).

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

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).

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

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).

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

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.

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

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.

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

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.

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

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., ( printed page 71798) programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

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

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).

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

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.

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

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).

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

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).

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

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).

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

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).

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

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).

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

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).

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

Propoxyphene test system.
* * * * *
( 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).

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

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).

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

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).

PART 864—HEMATOLOGY AND PATHOLOGY DEVICES

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

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

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

( 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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES

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

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

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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. ( printed page 71801)

Table 1—Class II Exempt Allergens Under § 866.5750—Radioallergosorbent (RAST) Immunological Test Systems
Allergen code Allergen product Source (taxonomical name)
Grass Pollens
g1 Sweet vernal grass Anthoxanthum odoratum.
g3 Cocksfoot grass, Orchard grass Dactylis glomerata.
g4 Meadow fescue Festuca elatior.
g5 Rye-grass (perennial rye grass) Lolium perenne.
g7 Common reed (common reed grass) Phragmites communis.
g8 Meadow grass, Kentucky blue (June grass) Poa pratensis.
g9 Redtop, Bentgrass Agrostis stolonifera, Agrostis gigantea ( Agrostis alba).
g11 Brome grass Bromus inermis.
g12 Cultivated rye (cultivated rye grass) Secale cereale.
g13 Velvet grass Holcus lanatus.
g14 Cultivated oat (cultivated oat grass) Avena sativa.
g15 Cultivated wheat (cultivated wheat grass) Triticum aestivum ( Triticum spp.).
g16 Meadow foxtail (meadow foxtail grass) Alopecurus pratensis.
g17 Bahia grass Paspalum notatum.
g24 Wheat grass, Western Agropyron smithii ( Elymus smithii).
g30 Bluegrass, annual Poa annua.
g70 Wild rye grass Elymus triticoidesElymus condensatus.
g71 Canary grass Phalaris arundinacea.
g201 Barley, cultivated Hordeum vulgare.
g202 Maize, corn (cultivated corn) Zea mays.
g203 Salt grass Distichlis spicata.
g204 False oat-grass Arrhenatherum elatius.
g216 Cyn d 1 Cynodon dactylon.
g701 Phl p 1.0102, Phl p 5.0101 Phleum pratense.
g702 Phl p 7.0101 Phleum pratense.
g703 Phl p 12.0101 Phleum pratense.
Weed Pollens
w2 Western ragweed Ambrosia psilostachya.
w4 False ragweed Ambrosia acanthicarpa ( Franseria acanthicarpa).
w5 Wormwood Artemisia absinthiumArtemisia annua.
w6 Mugwort Artemisia vulgaris.
w7 Marguerite, ox-eye daisy Chrysanthemum leucanthemum.
w8 Dandelion Taraxacum vulgare, Taraxacum officinale.
w9 Plantain (English), Ribwort Plantago lanceolata.
w10 Goosefoot, lamb's quarters Chenopodium album.
w11 Saltwort (prickly), Russian thistle Salsola kali ( Salsola pestifer).
w12 Goldenrod Solidago virgaurea ( Solidago spp.).
w13 Cocklebur, common Xanthium commune.
w14 Common pigweed (rough pigweed) Amaranthus retroflexus.
w15 Scale, Lenscale Atriplex lentiformis.
w16 Rough marsh elder Iva ciliate, Iva annua.
w17 Firebush (Kochia) Kochia scoparia.
w18 Sheep sorrel Rumex acetosella.
w19 Wall pellitory Parietaria officinalis.
w20 Nettle (Common stinging nettle) Urtica dioica.
w21 Wall pellitory Parietaria judaica.
w22 Japanese hop (careless weed) Humulus japonicas ( Humulus scandens).
w23 Yellow dock, Yellow dockweed Rumex crispus.
w24 Spiny pigweed Amaranthus spinosus.
w27 Carnation Dianthus spp.
w28 Rose Rosa rugosa.
w33 Clover Trifolium pratense.
w35 Mexican tea Chenopodium ambrosioides.
w36 Rabbit bush Ambrosia deltoidea ( Franseria deltoides).
w37 Salt bush, annual Atriplex wrightii.
w39 Water hemp, Western Amaranthus rudis ( Acnida tamariscina).
w41 Burrobrush Hymenoclea salsola.
w42 Poverty weed Baccharis neglecta.
w43 Common sagebrush Artemisia tridentata.
w45 Alfalfa Medicago sativa.
w46 Dog fennel Eupatorium capillifolium.
w53 Geranium Geranium spp.
w67 Groundsel bush Baccharis halimifolia.
w69 Iodine bush Allenrolfea occidentalis.
w70 Ragweed, slender Ambrosia confertiflora.
w75 Wing scale (wingscale) Atriplex canescens.
( printed page 71802)
w82 Careless weed Amaranthus palmeri, Amaranthus hybridus.
w90 Japanese hop Humulus japonicas ( Humulus scandens).
w203 Rape (rape pollen) Brassica napus.
w204 Sunflower Helianthus annuus.
w206 Camomile Matricaria chamomilla.
w207 Lupin Lupinus spp.
w210 Sugar-beet Beta vulgaris.
w211 Par j 2.0101 Parietaria judaica.
w231 Art v 1 Artemisia vulgaris (Mugwort).
w232 Sal k 1 Salsola kali.
w233 Art v 3 Artemisa vulgaris (LTP, Mugwort).
w234 Pla l 1 Plantago lanceolata.
w235 Che a 1.0101 Chenopodium album.
w236 Mer a 1.0101 Mercurialis annua.
a753 Art v 1 Artemisia vulgaris (Mugwort weed).
Tree Pollens
t1 Box-elder (Maple) Acer negundo, Acer saccharum.
t2 Gray alder, speckled alder (alder) Alnus incana.
t4 Hazel, hazelnut Corylus avellana, Corylus americana.
t5 American beech (beech) Fagus grandifolia ( Fagus americana).
t6 Mountain juniper, Mountain cedar Juniperus ashei ( Juniperus sabinoides).
t8 Elm Ulmus americana.
t9 Olive Olea europaea.
t10 Walnut Juglans californica, Juglans nigra.
t11 Maple leaf sycamore, London plane, Plane tree Platanus acerifolia.
t61 Sycamore Platanus occidentalis.
t12 Willow Salix caprea, Salix nigra.
t14 Cottonwood (Eastern Cottonwood/Black Cottonwood) Populus deltoides.
t15 White ash Fraxinus americana.
t16 White pine Pinus strobus.
t18 Eucalyptus, gum-tree Eucalyptus globulus ( Eucalyptus spp.).
t19/t26 Acacia Acacia longifolia ( Acacia spp.).
t20 Mesquite Prosopis glandulosa/Prosopis juliflora.
t21 Melaleuca, cajeput tree Melaleuca quinquenervia ( Melaleuca leucadendron).
t22 Pecan, hickory Carya illinoinensis ( Carya pecan).
t23 Italian/Mediterranean/funeral cypress Cupressus sempervirens.
t24 Japanese cypress Chamaecyparis obtusa ( Chamaecyparis spp.).
t25 Ash Fraxinus excelsior.
t27 Maple, red Acer rubrum.
t29 Acacia Acacia spp.
t30 Birch, white Betula populifolia.
t32 Willow, black Salix nigra.
t33 Ash, Arizona Fraxinus velutina.
t35 Cedar, salt Tamarix gallica.
t37 Bald cypress (white bald cypress) Taxodium distichum.
t38 Elm, Chinese/Siberian Ulmus pumila.
t40 Hazelnut tree Corylus americana.
t41 White hickory Carya alba ( Carya tomentosa).
t42 Oak, red Quercus rubra.
t43 Loblolly pine Pinus taeda.
t44 Hackberry Celtis occidentalis.
t45 Cedar elm Ulmus crassifolia.
t47 Juniper, one seed Juniperus monosperma.
t48 Pine, lodgepole Pinus contorta.
t49 Pine, ponderosa Pinus ponderosa.
t50 Beech, European Fagus sylvatica.
t51 Tree of Heaven Ailanthus altissima.
t52 Western white pine Pinus monticola.
t54 Russian olive Elaeagnus angustifolia.
t55 Scotch broom Cytisus scoparius.
t56 Bayberry Myrica cerifera.
t57 Red cedar Juniperus virginiana.
t60 Western juniper Juniperus occidentalis.
t61 Sycamore Platanus occidentalis.
t70 Mulberry (white mulberry) Morus alba.
t71 Red mulberry Morus rubra.
t72 Queen palm Arecastrum romanzoffiamon.
t73 Australian pine Casuarina equisetifolia.
( printed page 71803)
t77 Oak mix (red, white, black) Quercus spp.
t80 Japanese cypress Chamaecyparis obtusa.
t81 Japanese alder Alnus japonica.
t83 Mango tree Mangifera indica.
t90 Walnut, black Juglans nigra.
t96 Poplar, white (poplar) Populus alba.
t103/t218 Virginia live oak (live oak) Quercus virginiana.
t105 Pepper tree Schinus molle.
t110 Orange tree Citrus sinensis.
t201 Spruce, Norway spruce Picea abies ( Picea excelsa).
t202 Alder, smooth Alnus incana spp. Rugosa ( Alnus rugosa).
t203 Horse chestnut Aesculus hippocastanum.
t205 Elder Sambucus nigra.
t206 Chestnut Castanea sativa.
t207 Douglas fir Pseudotsuga menziesii ( Pseudotsuga taxifolia).
t208 Linden Tilia cordata.
t209 Horn beam Carpinus betulus.
t210 Privet Ligustrum vulgare.
t211 Sweet gum Liquidambar styraciflua.
t212 Cedar Libocedrus decurrens.
t213 Pine Pinus radiata.
t214 Date palm Phoenix canariensis.
t215 Lilac Syringa vulgaris.
t217 Pepper tree Schinus molle.
t217 Red alder Alnus rubra.
t218 Virginia live oak Quercus virginiana.
t218 Bayberry (bayberry/sweet gale) Myrica gale.
t219 Palo verde Cercidium floridum.
t219 Red cedar Juniperus virginiana.
t220 Bet v 4 Betula verrucosa (Birch).
t221 Bet v 2.0101, Bet v 4 Betula verrucosa (Birch).
t222 Cypress (Arizona cypress) Cupressus arizonica.
t223 Oil palm Elaeis guineensis.
t224 Ole e 1 Olea europaea.
t225 Bet v 6 Betula verrucosa (Birch).
t226 Cup a 1 Cupressus arizonica.
t227 Ole e 7 Olea Europaea.
t228 Aspen, quaking Populus tremuloides.
t229 Eastern hemlock Tsuga canadensis.
t230 Redwood (sequoia) Sequoia sempervirens.
t232 Pussy willow Salix discolor.
t240 Ole e 9.0101 Olea Europaea.
t241 Pla a 1.0101 Platanus acerifolia.
t242 Pla a 2 Platanus acerifolia.
t243 Pla a 3.0101 Platanus acerifolia.
t244 Cor a 1.0103 Corylus avellana.
t245 Aln g 1.0101 Alnus glutinosa.
t246 Cry j 1 Cryptomeria japonica.
t280 Locust tree Robinia pseudoacacia.
t401 Brazilian peppertree Schinus terebinthifolius.
t402 Mastic tree Pistacia lentiscus.
t404 Tree of heaven Ailanthus altissima.
t406 Date palm Phoenix dactylifera.
a482 Ole e 1 Olea europaea (Olive Oil).
Mites
d207 Blo t 5.0101 Blomia tropicalis.
d208 Lep d 2.0101 Lepidoglyphus destructor.
Microorganisms, Molds, Yeast
m1 Penicillium chrysogenum ( Penicillium notatum) Penicillium chrysogenum ( Penicillium notatum).
m2 Cladosporium herbarum ( Hormodendrum) Cladosporium herbarum ( Hormodendrum).
m3 Aspergillus fumigatus Aspergillus fumigatus.
m4 Mucor racemosus Mucor racemosus.
m5 Candida albicans Candida albicans.
m7 Botrytis cinerea Botrytis cinerea.
m8 Drechslera halodes ( Setomelanomma rostrata, Helminthosporium halodes, Helminthosporium interseminatum) Drechslera halodes ( Setomelanomma rostrata, Helminthosporium halodes.
( printed page 71804)
m9 Fusarium moniliforme ( Fusarium proliferatum) Fusarium moniliforme ( Fusarium proliferatum).
m10 Stemphylium botryosum Stemphylium herbarum ( Stemphylium botryosum).
m11 Rhizopus nigricans Rhizopus nigricans.
m12 Aureobasidium pullulans Aureobasidium pullulans.
m13 Phoma betae Phoma betae.
m14 Epicoccum purpurascens Epicoccum purpurascens ( Epicoccum nigrum).
m15 Trichoderma viride Trichoderma viride.
m16 Curvularia lunata Curvularia lunata, Curvularia specifera ( K923044).
m17 Cladosporium fulvum Cladosporium fulvum.
m18 Fusarium culmorum Fusarium culmorum.
m19 Aspergillus versicolor Aspergillus versicolor.
m20 Mucor mucedo Mucor mucedo.
m21 Aspergillus clavatus Aspergillus clavatus.
m22 Micropolyspora faeni Saccharopolyspora rectivirgula ( Micropolyspora faeni).
m23 Thermoactinomyces vulgaris Thermoactinomyces vulgaris.
m24 Stachybotrys atra Stachybotrys chartarum ( Stachybotrys atra).
m24 Paecilomyces spp Paecilomyces spp.
m25 Aspergillus versicolor Aspergillus versicolor.
m25 Penicillium brevicompactum Penicillium brevicompactum.
m26 Cladosporium cladosporioides Cladosporium cladosporioides.
m26 Penicillium citrinum Penicillium citrinum.
m27 Penicillium spp Penicillium spp.
m29 Aspergillus repens Aspergillus repens.
m30 Penicillium roqueforti Penicillium roqueforti.
m32 Cladosporium cladosporioides Cladosporium cladosporioides.
m34 Serpula lacrymans Serpula lacrymans.
m36 Aspergillus terreus Aspergillus terreus.
m37 Trichophyton mentagrophytes Trichophyton mentagrophytes.
m40 Aspergillus amstelodami Aspergillus amstelodami.
m43 Saccharomyces Carlsberg Saccharomyces carlsbergensis.
m44 Saccharomyces cerevisiae Saccharomyces cerevisiae.
m45 Hormodendrum hordei Hormodendrum hordei.
m46 Bipolaris spicifera Bipolaris spicifera.
m47 Aspergillus nidulans Aspergillus nidulans.
m48 Aspergillus oryzae Aspergillus oryzae.
m49 Fusarium oxysporum Fusarium oxysporum.
m50 Micropolyspora faeni Saccharopolyspora rectivirgula ( Micropolyspora faeni).
m51 Thermoactinomyces vulgaris Thermoactinomyces vulgaris.
m53 Microspora canis Microsporum canis ( Microspora canis).
m54 Aspergillus flavus Aspergillus flavus.
m63 Helminthosporium intersemin Helminthosporium intersemin.
m66 Mucor plumbeus Mucor plumbeus.
m67 Mycogone Mycogone perniciosa.
m68 Nigrospora oryzae Nigrospora oryzae.
m69 Rhodotorula Rhodotorula rubra ( Rhodotorula mucilaginosa).
m70 Malassezia furfur ( Pityrosporum orbiculare) Malassezia furfur ( Pityrosporum orbiculare).
m71 Spondylocladium Spondylocladium spp.
m72 Epidermophyton Epidermophyton floccosum.
m73 Epicoccum nigrum Epicoccum purpurascens ( Epicoccum nigrum).
m80 Staphylococcal enterotoxin A ( Sta a SEA) Staphylococcus aureus.
m80 Helminthosporium spp Helminthosporium spp.
m81 Staphylococcal enterotoxin B ( Sta a SEB) Staphylococcus aureus.
m88 Stemphylium solani Stemphylium solani.
m93 Gliocladium fimbriatum Gliocladium fimbriatum.
m94 Phycomyces blakesleeanus Phycomyces blakesleeanus.
m201 Tilletia tritici ( Ustilago nuda, Ustilago tritici) (Barley smut) Tilletia tritici ( Ustilago nuda, Ustilago tritici).
m202 Acremonium kiliense ( Cephalosporium acremonium) Acremonium kiliense ( Cephalosporium acremonium).
m203 Trichosporon pullulans Trichosporon pullulans.
m204 Ulocladium chartarum Ulocladium chartarum.
m205 Trichophyton rubrum Trichophyton rubrum.
m207 Aspergillus niger Aspergillus niger.
m208 Chaetomium globosum Chaetomium globosum.
m209 Penicillium frequentans Penicillium glabrum ( Penicillium frequentans).
m209 Stachybotrys chartarum Stachybotrys chartarum ( Stachybotrys atra).
m210 Trichophyton mentagrophytes var. goetzii Trichophyton mentagrophytes var. goetzii.
m211 Trichophyton mentagrophytes var. interdigitale Trichophyton mentagrophytes var. interdigitale.
m211 Oat smut Ustilago avenae.
m212 Micropolyspora faeni Saccharopolyspora rectivirgula ( Micropolyspora faeni).
m212 Geotrichum candidum Geotrichum candidum.
m213 Bermuda grass smut Ustilago cynodontis.
( printed page 71805)
m214 Johnson grass smut Sphacelotheca cruenta.
m215 Corn smut Ustilago maydis.
m218 Asp f 1.0101 Aspergillus fumigatus.
a3050 Asp r 1 Aspergillus restrictus.
m219 Asp f 2 Aspergillus fumigatus.
m220 Asp f 3.0101 Aspergillus fumigatus.
m221 Asp f 4 Aspergillus fumigatus.
m222 Asp f 6.0101 Aspergillus fumigatus.
m223 Staphylococcal enterotoxin C ( Sta a SEC) Staphylococcus aureus.
m224 Staphylococcal enterotoxin D ( Sta a SED) Staphylococcus aureus.
m226 Staphylococcal enterotoxin TSST ( Sta a TSST) Staphylococcus aureus.
m227 Malassezia spp. ( Pityrosporum spp.) Malassezia spp. ( Pityrosporum spp.).
m228 Aspergillus flavus.
m229 Alt a 1.0101 Alternaria alternata ( Alternaria tenuis).
m230 Alt a 6.0101 Alternaria alternata ( Alternaria tenuis).
m231 Cla h 8.0101 Cladosporium herbarum ( Hormodendrum).
m300 Eurotium spp Eurotium spp.
m304 Aspergillus oryzae Aspergillus oryzae.
m305 Penicillium brevicompactum Penicillium brevicompactum.
m309 Aspergillus terreus Aspergillus terreus.
m310 Aspergillus nidulans Aspergillus nidulans.
m311 Aspergillus flavus Aspergillus flavus.
m312 Aspergillus clavatus Aspergillus clavatus.
Epidermal & Animal
e6 Guinea pig epithelium Cavia porcellus.
e7 Pigeon droppings Columba palumbus, Columba livia.
e25 Chicken serum Gallus domesticus ( Gallus gallus domesticus; Gallus spp.).
e26 Parrot serum Psittacoidea spp.
e62 Camel Camelus dromedaries.
e70 Goose feathers Anser anser.
e71 Mouse epithelium Mus musculus ( Mus spp.).
e73 Rat epithelium Rattus norvegicus.
e74 Rat urine proteins Rattus norvegicus, Rattus rattus.
e75 Rat serum proteins Rattus norvegicus, Rattus rattus.
e76 Mouse serum proteins Mus musculus ( Mus spp.).
e77 Budgerigar droppings Melopsittacus undulatus.
e78 Budgerigar feathers Melopsittacus undulatus.
e79 Budgerigar serum proteins Melopsittacus undulatus.
e80 Goat epithelium Capra hircus.
e81 Sheep epithelium Ovis aries ( Ovis spp.).
e82 Rabbit epithelium Oryctolagus cuniculus ( Oryctolagus spp.).
e83 Swine epithelium Sus scrofa ( Sus scrofa domesticus; Sus spp.).
e84 Hamster epithelium Cricetus cricetus, Mesocricetus auratus, and Phodopus sungorus.
e85 Chicken feathers Gallus domesticus ( Gallus gallus domesticus; Gallus spp.).
e86 Duck feathers Anas platyrhynchos.
e87 Rat epithelium, serum proteins, and urine proteins Rattus norvegicusRattus rattus.
e88 Mouse epithelium, serum proteins, and urine proteins (mouse) Mus musculus ( Mus spp.).
e89 Turkey feathers Meleagris gallopavo.
e90 Budgerigar serum proteins, feathers, and droppings Melopsittacus undulatus.
e91 Pigeon serum proteins, feathers, and droppings Streptopelia roseogrisea, Psittacidae spp.
e92 Parrot serum proteins, feathers, and droppings Ara spp.
e93 Pigeon serum proteins Streptopelia roseogrisea.
e94 Fel d 1.0101 Felis domesticus.
a345 Fel d 1 Felis domesticus.
e98 Parrot droppings Psittacoidea spp.
e101 Can f 1.0101 Canis familiaris ( Canis domesticus).
a174 Can f 1 Canis familiaris ( Canis domesticus).
e102 Can f 2.0101 Canis familiaris ( Canis domesticus).
e196 Parakeet feathers Nymphicus hollandicus.
e197 Parakeet droppings Nymphicus hollandicus.
e198 Parakeet serum Nymphicus hollandicus.
e199 Canary bird serum Serinus canarius.
e200 Canary bird droppings Serinus canarius.
e201 Canary bird feathers (Canary feathers) Serinus canarius.
e202 Reindeer epithelium Rangifer tarandus.
e203 Mink epithelium Mustela spp.
( printed page 71806)
e204 Bos d 6 Bos domesticus ( Bos taurus; Bos spp.).
e205 Horse, serum proteins Equus caballus ( Equus spp.).
e206 Rabbit, serum proteins Oryctolagus cuniculus ( Oryctolagus spp.).
e208 Chinchilla epithelium Chinchilla laniger.
e209 Gerbil epithelium Meriones unguiculatus.
e210 Fox epithelium Vulpes vulpes.
e211 Rabbit, urine proteins Oryctolagus cuniculus ( Oryctolagus spp.).
e212 Swine, urine proteins Sus scrofa ( Sus scrofa domesticus; Sus spp.).
e213 Parrot feathers Ara spp.
e214 Finch feathers Lonchura domestica.
e215 Pigeon feathers Streptopelia roseogrisea ( Streptopelia spp.), Columbia spp.
e216 Deer epithelium Dama dama.
e217 Ferret epithelium Mustela putorius.
e218 Chicken droppings Gallus domesticus ( Gallus gallus domesticus; Gallus spp.).
e219 Chicken, serum proteins Gallus domesticus ( Gallus gallus domesticus; Gallus spp.).
e220 Fel d 2, Cat serum albumin Felis domesticus.
e221 Can f 3 Canis familiaris ( Canis domesticus) ( Dog serum albumin).
e222 Swine serum albumin (Sus s PSA) Sus scrofa ( Sus scrofa domesticus; Sus spp.).
e225 Lovebird feathers Psittacoidea agapomis.
e226 Can f 5.0101 Canis familiaris.
e227 Equ c 1.0101 Equus caballus.
e228 Fel d 4.0101 Felis domesticus.
e230 Equ c 3 Equus caballus.
e231 Mus m 1 Mus musculus.
Food
f9 Rice Oryza sativa.
f12 Pea (green pea) Pisum sativum.
f15 White bean Phaseolus vulgaris.
f19 Cayenne pepper Capsicum frutescens ( Capsicum annum).
f21 Sugar cane Saccharum officinarum.
f22 Raspberry Rubus idaeus.
f26 Pork Sus scrofa ( Sus scrofa domesticus; Sus spp.).
f29 Watermelon Citrullus lanatus ( Citrullus vulgaris).
f31 Carrot Daucus carota.
f32 Oyster mushroom Pleurotus ostreatus.
f33 Orange Citrus sinensis.
f35 Potato Solanum tuberosum.
f43 Mother's milk Homo sapiens.
f44 Strawberry Fragaria vesca ( Fragaria spp.).
f45 Yeast, baker's Saccharomyces cerevisiae.
f46 Pepper, Red Capsicum annuum.
f47 Garlic Allium sativum.
f48 Onion Allium cepa.
f49 Apple Malus x domestica ( Malus spp.).
f51 Bamboo shoot Phyllostachys pubescens.
f52 Cacao/chocolate Theobroma cacao.
f54 Sweet potato Ipomoea batatas.
f55 Common millet Panicum miliaceum.
f56 Foxtail millet Setaria italica.
f57 Japanese millet Echinochloa crus-galli.
f58 Pacific squid Todarodes pacificus.
f59 Octopus Octopus vulgaris ( Octopus spp.).
f63 Kefir NA.
f67 Parmesan cheese NA.
f81 Cheese, cheddar type NA.
f82 Cheese, mold type NA.
f83 Chicken Gallus domesticus ( Gallus gallus domesticus; Gallus spp.).
f86 Parsley Petroselinum crispum.
f87 Melon Cucumis melo Cucumis melo + Citrullus lanatus.
f88 Mutton (lamb) Ovis aries ( Ovis spp.).
f90 Malt Hordeum vulgare.
f92 Banana Musa spp.
f93 Cacao Theobroma cacao.
f94 Pear Pyrus communis ( Pyrus spp.).
f97 Yam Dioscorea spp. Dioscorea opposita.
f97 Chamomile tea Matricaria chamomilla.
f98 Gliadin Triticum aestivum ( Triticum spp.).
f102 Cantaloupe Cucumis melo var. cantalupensis.
( printed page 71807)
f105 Chocolate Theobroma cacao.
f109 Cottonseed Gossypium hirsutum.
f110 Giant radish Raphanus sativus.
f118 Zucchini Cucurbita pepo.
f119 Radish Raphanus sativus.
f120 Venison Capreolus capeolus.
f121 Pinto bean Phaseolus vulgaris.
f122 Cheese, American NA.
f127 Black-eyed pea Vigna unguiculata.
f131 Black Olive Olea europaea.
f136 Red beet Beta vulgaris var. conditiva.
f139 Goat's Cheese Capra aegagrus.
f140 Bran NA.
f141 Corn (vegetables) Zea mays.
f152 Green bell pepper Capsicum annuum.
f155 Brewer's yeast Saccharomyces carlsbergensis.
f157 Duck Anas domesticus.
f158 Goose Anser anser.
f160 Camembert cheese NA.
f162 Nectarine Prunus persica var. nucipersica.
f163 Kohlrabi Brassica oleracea var. gongylodes.
f65 Perch
f166 Leek Allium porrum.
f170 Cheese (Switzerland) (Swiss cheese) NA.
f174 Fig Ficus carica.
f177 Cranberry Vaccinium macrocarpon.
f179 Raisin Vitis spp.
f182 Lima bean Phaseolus lunatus.
f198 Flaxseed (bruised grain) Linum usitatissimum.
f199 Untreated native milk Bos domesticus ( Bos taurus; Bos spp.).
f208 Lemon Citrus limon.
f209 Grapefruit Citrus paradisi.
f210 Pineapple Ananas comosus.
f211 Blackberry Rubus fruticosus.
f212 Mushroom (champignon) Agaricus hortensis ( Agaricus spp.).
f213 Rabbit Oryctolagus cuniculus ( Oryctolagus spp.).
f214 Spinach Spinacia oleracea.
f215 Lettuce Lactuca sativa.
f216 Cabbage Brassica oleracea var. capitata.
f217 Brussels sprouts Brassica oleracea var. gem.
f218 Paprika, sweet pepper Capsicum annuum.
f219 Fennel seed Foeniculum vulgare.
f219 Sage Salvia officinalis.
f220 Cinnamon Cinnamomum spp.
f221 Coffee Coffea spp.
f222 Tea Camellia sinensis.
f223 Green olive Olea europaea.
f225 Summer squash, pumpkin Cucurbita pepo.
f225 Pumpkin Cucurbita maxima.
f226 Pumpkin seed Cucurbita pepo.
f227 Sugar-beet seed Beta vulgaris.
f229 Safflower Seed Carthamus tinctorius.
f231 Milk, boiled Bos domesticus ( Bos taurus; Bos spp.).
f234 Vanilla Vanilla planifolia.
f237 Apricot Prunus armeniaca.
f241 Gouda cheese NA.
f242 Cherry Prunus avium.
f244 Cucumber Cucumis sativus.
f246 Guar, guar gum Cyamopsis tetragonoloba.
f247 Honey NA.
f248 Rosemary Rosmarinus officinalis.
f254 Plaice Pleuronectes platessa.
f255 Plum Prunus domestica, Prunus americana.
f258 Squid Loligo spp.
f259 Grape Vitis vinifera ( Vitis spp.).
f260 Broccoli Brassica oleracea var. italica ( Brassica oleracea var. cultivar).
f261 Asparagus Asparagus officinalis.
f262 Aubergine, eggplant Solanum melongena.
f263 Green pepper Piper nigrum, Capsicum annuum.
( printed page 71808)
f264 Eel Anguilla anguilla.
f265 Caraway Carum carvi.
f265 Cumin Cuminum cyminum.
f266 Mace Myristica fragrans.
f267 Cardamon Elettaria cardamomum.
f268 Clove Syzygium aromaticum.
f269 Basil Ocimum basilicum.
f270 Ginger Zingiber officinale.
f271 Anise Pimpinella anisum.
f272 Tarragon Artemisia dracunculus.
f273 Thyme Thymus vulgaris.
f274 Marjoram Origanum majorana.
f275 Lovage Levisticum officinale.
f276 Fennel, fresh Foeniculum vulgare.
f277 Dill Anethum graveolens.
f278 Bay leaf Laurus nobilis.
f279 Chili pepper Capsicum frutescens.
f280 Black pepper Piper nigrum.
f281 Curry (Santa Maria) NA.
f282 Nutmeg Myristica fragrans.
f283 Oregano Origanum vulgare.
f284 Turkey meat Meleagris gallopavo.
f285 Elk/moose meat Alces spp.
f286 Mare's milk Equus caballus ( Equus spp.).
f287 Red kidney bean Phaseolus vulgaris.
f288 Blueberry Vaccinium myrtillus ( Vaccinium spp.).
f289 Date Phoenix dactylifera.
f291 Cauliflower Brassica oleracea var. botrytis.
f292 Guava Psidium guajava.
f293 Papaya Carica papaya.
f294 Passion fruit, Maracuja Passiflora edulis ( Passiflora spp.).
f295 Carambola Averrhoa carambola.
f296 Carob Ceratonia siliqua.
f297 Gum Arabic Acacia senegal ( Acacia spp.).
f298 Tragacanth Astragalus spp.
f299 Sweet chestnut (chestnut) Castanea sativa.
f300 Pinto bean Phaseolus spp.
f301 Persimmon (kaki fruit, sharon) Diospyros kaki.
f302 Mandarin (tangerine, clementine, satsumas) Citrus reticulata.
f305 Fenugreek Trigonella foenum-graecum.
f306 Lime Citrus aurantifolia.
f307 Hake Merluccius merluccius.
f308 Sardine (pilchard) Sardina pilchardus.
f310 Blue vetch Lathyrus sativus.
f311 Megrim Lepidorhombus whiffiagonis.
f315 Green bean Phaseolus vulgaris.
f316 Rape seed Brassica napus.
f317 Coriander Coriandrum sativum.
f318 Jack fruit Artocarpus heterophyllus.
f319 Beetroot Beta vulgaris.
f320 Crayfish Astacus astacus.
f321 Horse meat Equus caballus ( Equus spp.).
f322 Red currant Ribes sylvestre.
f324 Hop (fruit cone) Humulus lupulus.
f325 Saffron Colchicum autumnale.
f328 Fig Ficus carica.
f329 Watermelon Citrullus lanatus.
f330 Rose hip Rosa spp.
f331 Saffron Crocus sativus.
f332 Mint Mentha piperita.
f333 Linseed Linum usitatissimum.
f336 Jujube Ziziphus jujuba.
f336 Wine vinegar Vitis vinifera ( Vitis spp.).
f337 Sole Solea solea.
f337 English sole Parophrys vetulus.
f338 Wine, white Vitis vinifera ( Vitis spp.).
f339 Allspice Pimenta dioica.
f339 Wine, red Vitis vinifera ( Vitis spp.).
f341 Cranberry Vaccinium oxycoccus, Vaccinium macrocarpon.
f342 Olive (black, fresh) Olea europaea.
( printed page 71809)
f343 Raspberry Rubus idaeus.
f344 Sage Salvia officinalis.
f346 Chives Allium schoenoprasum.
f347 Quinoa Chenopodium quinoa.
f348 Litchi Litchi chinensis.
f349 Chum salmon roe Oncorhynchus keta.
f358 Artichoke Cynara scolymus.
f360 Yogurt NA.
f368 Black bass Micropterus dolomieu ( Micropterus dolomieui).
f374 Karaya gum Sterculia urens.
f375 Horseradish Armoracia rusticana.
f377 Maple syrup NA.
f379 Okra Abelmoschus esculentus.
f382 Beet, sugar Beta vulgaris var. altissima.
f401 Loquat Eriobotrya japonica.
f402 Fig Ficus carica.
f403 Brewer's yeast Saccharomyces cerevisiae.
f405 Mint Mentha spp.
f406 Arugula Eruca vesicaria.
House Dust
h1 Greer Labs., Inc NA.
h2 Hollister-Stier Labs NA.
h6 Japan NA.
Venoms & Insects
i7 Midge Chironomus yoshimatsui.
i8 Moth Bombyx mori, Heterocera spp.
i47 Water flea Daphnia spp.
i49 Deer fly Chrysops spp.
i51 Black ant Camponotus pennsylvanicus.
i54 Flea mix (dog/cat), common flea Ctenocephalides spp.
i71 Mosquito Aedes communis, Aedes spp. and Culex spp.
i72 Green nimitti Cladotanytarsus lewisi.
i73 Blood worm Chironomus thummi, Chironomusri parius, Chironomus spp.
i75 European hornet Vespa crabro.
i76 Berlin beetle Trogoderma angustum.
i77 European paper wasp Polistes dominulus.
i78 Fly Musca domestica.
i80 Bumblebee Bombus pennsylvanicus.
i201 Horse bot fly Gasterophilus intestinalis.
i202 Grain weevil Sitophilus granarius.
i203 Mediterranean flour moth Ephestia kuehniella ( Anagasta kuehniella).
i204 Horse fly Tabanus spp.
i205 Bumblebee Bombus terrestris.
i208 Api m 1.0101 Apis mellifera.
a45 Api m 1 Apis mellifera.
i209 Ves v 5.0101 Vespula vulgaris.
a670 Ves v 5 Vespula vulgaris.
i210 Pol d 5.0101 Polistes dominulus.
i211 Ves v 1.0101 Vespula vulgaris.
i213 Api m 4 Apis mellifera.
i214 Api m 2 Apis mellifera.
i215 Api m 3 Apis mellifera.
i216 Api m 5 Apis mellifera.
i217 Api m 10 Apis mellifera.
i220 Bla g 1.0101 Blattella germanica.
i221 Bla g 2.0101 Blattella germanica.
i222 Bla g 5.0101 Blattella germanica.
i223 Bla g 7 Blattella germanica.
a46 Api m 2 Apis mellifera.
Miscellaneous
o1 Cotton, crude fibers Gossypium spp.
o3 Cotton (treated) Gossypium spp.
o70 Seminal fluid Homo sapiens.
o71 Staphylococcus aureus Staphylococcus aureus.
( printed page 71810)
o72 Pichia pastoris crude extract customer specific Pichia pastoris.
o72 Sperm-sediment Homo sapiens.
o73 Pichia pastoris crude extr. vector customer specific Pichia pastoris.
o74 Pichia pastoris with vector customer specific Pichia pastoris.
o201 Tobacco leaf, tobacco dust Nicotiana tabacum.
o202 Artemia salina, fish feed Artemia salina.
o203 Tetramin, fish feed NA.
o207 Daphnia, fish feed Daphnia spp.
o211 Mealworm Tenebrio molitor.
o212 Streptavidin Streptomyces avidini.
o213 MBP (maltose binding protein) Escherichia coli.
o214 CCD; MUXF3 from bromelain Ananas comosus.
o72 Enterotoxin A (Sta a SEA) Staphylococcus aureus.
o73 Enterotoxin B (Sta a SEB) Staphylococcus aureus.
Parasites
p1 Ascaris Ascaris suum.
p2 Echinococcus Echinococcus granulosus.
p3 Schistosoma Schistosoma mansoni.
p4 Anisakis (Herring Worm) Anisakis simplex ( Anisakis spp.).
p5 Toxocara canis Toxocara canis.
p10 Ani s 3.0101 Anisakis simplex ( Anisakis spp.).
p11 Ani s 1 Anisakis simplex ( Anisakis spp.).
Occupational
k4 Threshing dust NA.
k5 Flax NA.
k7 Hay Dust NA.
k8 Hop (hops) Humulus lupulus.
k12 Grain mill dust NA.
k14 Kapok NA.
k20 Sheep's wool (treated) (wool) Ovis aries ( Ovis spp.).
k21 Sheep's wool (Untreated) Ovis aries ( Ovis spp.).
k23 Straw Dust NA.
k33 Oak NA.
k70 Green coffee bean Coffea spp.
k71 Castor bean Ricinus communis.
k72 Ispaghula Plantago psyllium/Plantago ovata.
k73 Silk waste NA.
k74 Silk Bombyx mori.
k75 Isocyanate TDI (Toluene diisocyanate) NA.
k76 Isocyanate MDI (Diphenylmethane diisocyanate) NA.
k77 Isocyanate HDI (Hexamethylen diisocyanate) NA.
k78 Ethylene oxide NA.
k79 Phthalic anhydride NA.
k80 Formaldehyde/Formalin NA.
k81 Ficus Ficus benjamina ( Ficus spp.).
k83 Cotton seed Gossypium hirsutum.
k84 Sunflower seed Helianthus annuus.
k85 Chloramin T NA.
k86 Trimellitic anhydride, TMA NA.
k87 Asp o 21, alpha-amylase Aspergillus oryzae.
k89 Orris root Iris florentina.
k99 HSA (Human Serum Albumin) (Hom s HSA) Homo sapiens.
k201 Car p 1, Papain Carica papaya.
k202 Ana c 2, Bromelain Ananas comosus.
k204 Maxatase Bacillus licheniformis.
k205 Alcalase Bacillus spp.
k206 Savinase, Protease 1 (Bac l Subtilisin) Bacillus spp.
k208 Gal d 4, Lysozyme Gallus domesticus ( Gallus gallus domesticus; Gallus spp.).
k209 Hexahydrophtalic anhydrid NA.
k210 Maleic anhydride NA.
k211 Methyltetrahydrophtalic anhydrid NA.
k212 Abachi wood dust Triplochiton scleroxylon.
k213 Pepsin (Sus s Pepsin) Sus scrofa ( Sus scrofa domesticus; Sus spp.).
k213 TCPA NA.
k214 Bougainvillea Bougainvillea spp.
k225 Horse radish peroxidase (Arm r HRP) Armoracia rusticana.
( printed page 71811)
k226 Ascorbate oxidase (Cuc p ascorbate oxidase) Cucurbita pepo.
k301 Flour dust Triticum spp.
k501 Savinase customer specific Proprietary knowledge of customer.
k502 Lipolase customer specific Proprietary knowledge of customer.
k503 Termamyl customer specific Proprietary knowledge of customer.
k504 Clazinase customer specific Proprietary knowledge of customer.

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

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.

PART 868—ANESTHESIOLOGY DEVICES

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

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

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

PART 870—CARDIOVASCULAR DEVICES

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

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

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

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.

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

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.

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

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.

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

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.

( printed page 71812)

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

PART 872—DENTAL DEVICES

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

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

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

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.

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

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.

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

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.

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

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:

* * * * *

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

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:

* * * * *

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

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.

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

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:

* * * * *

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

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.

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

Teething ring.
* * * * *

(b) * * * ( 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.

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

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.

PART 874—EAR, NOSE, AND THROAT DEVICES

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

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

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

PART 876—GASTROENTEROLOGY-UROLOGY DEVICES

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

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

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

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.

* * * * *

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

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.

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

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.

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

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.

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

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.

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

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.

( printed page 71814)

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

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.

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

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:

* * * * *

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

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.

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

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.

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

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.

* * * * *

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

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.

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

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.

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

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.

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

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.

* * * * *

PART 878—GENERAL AND PLASTIC SURGERY DEVICES

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

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

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

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.

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

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.

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

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.

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

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.

PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES

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

( printed page 71815) Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

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

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:

* * * * *

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

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.

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

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.

* * * * *

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

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.

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

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.

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

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.

PART 882—NEUROLOGICAL DEVICES

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

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

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

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.

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

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.

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

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:

* * * * *

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

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.

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

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.

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

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.

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

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.

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

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.

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

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:

* * * * *

PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES

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

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

( printed page 71816)

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

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.

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

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.

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

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.

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

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.

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

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.

* * * * *

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

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.

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

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:

* * * * *

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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 ( printed page 71817) it 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.

PART 886—OPHTHALMIC DEVICES

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

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

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

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.

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

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.

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

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.

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

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.

* * * * *

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

Ophthalmic sponge.
* * * * *
( 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.

PART 888—ORTHOPEDIC DEVICES

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

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

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

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.

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

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.

PART 890—PHYSICAL MEDICINE DEVICES

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

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

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

PART 892—RADIOLOGY DEVICES

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

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

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

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.

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

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.

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

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.

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

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.

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

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.

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

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 ( printed page 71819) part 807 of this chapter subject to the limitations in § 892.9.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

Dated: December 13, 2019.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

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.

Back to Citation

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

BILLING CODE 4164-01-P

Published Document: 2019-27394 (84 FR 71794)