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. 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
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.
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
2 Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/procedures-class-ii-device-exemptions-premarket-notification-guidance-industry-and-cdrh-staff.
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 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, 360l, 371.
2. In § 862.1020, revise paragraph (b) to read as follows:
§ 862.1020
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:
§ 862.1090
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:
§ 862.1100
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:
§ 862.1150
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:
§ 862.1345
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:
§ 862.1350
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:
§ 862.1410
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:
§ 862.1415
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:
§ 862.1445
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:
§ 862.1509
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:
§ 862.1580
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:
§ 862.1660
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 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:
§ 862.1685
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:
§ 862.1700
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:
§ 862.1775
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:
§ 862.2265
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:
§ 862.2570
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:
§ 862.3050
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:
§ 862.3100
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:
§ 862.3150
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:
§ 862.3170
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:
§ 862.3200
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:
§ 862.3220
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:
§ 862.3240
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:
§ 862.3250
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.,
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:
§ 862.3270
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:
§ 862.3280
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:
§ 862.3580
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:
§ 862.3610
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:
§ 862.3620
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:
§ 862.3630
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:
§ 862.3640
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:
§ 862.3650
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:
§ 862.3700
Propoxyphene test system.
(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:
§ 862.3870
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:
§ 862.3910
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, 360l, 371.
39. In § 864.5400, revise paragraph (b) to read as follows:
§ 864.5400
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:
§ 864.5425
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:
§ 864.6550
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:
§ 864.7040
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:
§ 864.7275
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:
§ 864.7300
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:
§ 864.7340
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:
§ 864.7375
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:
§ 864.7415
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:
§ 864.7455
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:
§ 864.7500
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:
§ 864.7720
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:
§ 864.7735
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:
§ 864.8150
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:
§ 864.8165
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:
§ 864.8175
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:
§ 864.8185
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:
§ 864.8625
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:
§ 864.9400
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, 360l, 371.
59. In § 866.2900, revise paragraph (b) to read as follows:
§ 866.2900
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:
§ 866.3395
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:
§ 866.5210
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:
§ 866.5470
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:
§ 866.5620
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:
§ 866.5630
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:
§ 866.5750
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.
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 triticoides
Elymus 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 absinthium
Artemisia 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.
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.
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.
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.
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 norvegicus
Rattus 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.
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.
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.
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.
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.
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.
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:
§ 866.5910
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, 360l, 371.
68. In § 868.1040, revise paragraph (b) to read as follows:
§ 868.1040
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:
§ 868.2385
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:
§ 868.2500
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:
§ 868.2550
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:
§ 868.5180
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:
§ 868.6250
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, 360l, 371.
75. In § 870.1330, revise paragraph (b) to read as follows:
§ 870.1330
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:
§ 870.1390
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:
§ 870.1650
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:
§ 870.1875
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.
79. In § 870.2675, revise paragraph (b) to read as follows:
§ 870.2675
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:
§ 870.2770
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:
§ 870.4280
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:
§ 870.4290
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:
§ 870.4340
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:
§ 870.4400
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:
§ 870.4420
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:
§ 870.4430
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, 360l, 371.
88. In § 872.1720, revise paragraph (b) to read as follows:
§ 872.1720
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:
§ 872.3260
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:
§ 872.3300
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:
§ 872.3540
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:
§ 872.3560
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:
§ 872.3590
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:
§ 872.3600
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:
§ 872.3890
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:
§ 872.5550
Teething ring.
(b) * * *
(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:
§ 872.6770
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, 360l, 371.
99. In § 874.1090, revise paragraph (b) to read as follows:
§ 874.1090
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:
§ 874.1120
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:
§ 874.1325
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:
§ 874.3310
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:
§ 874.3320
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:
§ 874.3330
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:
§ 874.3430
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:
§ 874.3730
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, 360l, 371.
108. In § 876.1500, revise paragraph (b)(1) to read as follows:
§ 876.1500
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:
§ 876.4020
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:
§ 876.4270
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:
§ 876.4400
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:
§ 876.4500
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:
§ 876.4770
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.
114. In § 876.5010, revise paragraph (b) to read as follows:
§ 876.5010
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:
§ 876.5025
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:
§ 876.5160
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:
§ 876.5365
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:
§ 876.5520
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:
§ 876.5630
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:
§ 876.5665
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:
§ 876.5895
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:
§ 876.5980
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, 360l, 371.
124. In § 878.4370, revise paragraph (b) to read as follows:
§ 878.4370
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:
§ 878.4495
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:
§ 878.4580
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:
§ 878.5070
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:
Authority:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
129. In § 880.5580, revise paragraph (b) introductory text to read as follows:
§ 880.5580
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:
§ 880.5680
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:
§ 880.5780
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:
§ 880.6250
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:
§ 880.6375
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:
§ 880.6760
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, 360l, 371.
136. In § 882.1020, revise paragraph (b) to read as follows:
§ 882.1020
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:
§ 882.1030
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:
§ 882.1470
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:
§ 882.1540
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:
§ 882.1560
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:
§ 882.1855
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:
§ 882.4060
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:
§ 882.4545
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:
§ 882.5895
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, 360l, 371.
146. In § 884.1630, revise paragraph (b) to read as follows:
§ 884.1630
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:
§ 884.2990
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:
§ 884.3200
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:
§ 884.4400
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:
§ 884.4530
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:
§ 884.4900
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:
§ 884.5200
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:
§ 884.5390
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:
§ 884.5400
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:
§ 884.5425
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:
§ 884.5435
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:
§ 884.6120
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:
§ 884.6130
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:
§ 884.6150
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:
§ 884.6160
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 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, 360l, 371.
162. In § 886.1120, revise paragraph (b) to read as follows:
§ 886.1120
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:
§ 886.1250
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:
§ 886.1570
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:
§ 886.1780
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:
§ 886.1850
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:
§ 886.1945
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:
§ 886.3320
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:
§ 886.4070
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:
§ 886.4150
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:
§ 886.4250
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:
§ 886.4335
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:
§ 886.4400
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:
§ 886.4440
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:
§ 886.4790
Ophthalmic sponge.
(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, 360l, 371.
177. In § 888.1240, revise paragraph (b) to read as follows:
§ 888.1240
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:
§ 888.4580
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, 360l, 371.
180. In § 890.1450, revise paragraph (b) to read as follows:
§ 890.1450
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:
§ 890.5100
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:
§ 890.5110
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:
§ 890.5250
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:
§ 890.5360
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:
§ 890.5500
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:
§ 890.5575
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, 360l, 371.
188. In § 892.1000, revise paragraph (b) to read as follows:
§ 892.1000
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:
§ 892.1560
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:
§ 892.1610
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:
§ 892.1650
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:
§ 892.1670
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:
§ 892.1680
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 part 807 of this chapter subject to the limitations in § 892.9.
194. In § 892.1730, revise paragraph (b) to read as follows:
§ 892.1730
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:
§ 892.1820
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:
§ 892.1850
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:
§ 892.1860
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:
§ 892.1870
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:
§ 892.1900
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:
§ 892.2030
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:
§ 892.2040
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:
§ 892.5730
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.