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

Federal RegisterDec 30, 2019

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888, 890, and 892

[Docket Nos. FDA-2017-N-1129 and FDA-2017-N-1610]

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

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final amendment; final order.

SUMMARY:

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

DATES:

This order is effective December 30, 2019.

FOR FURTHER INFORMATION CONTACT:

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

karen.fikes@fda.hhs.gov.

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.

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 ”.

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, 360

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.

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.

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, 360

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, 360

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

Sweet vernal grass

Anthoxanthum odoratum.

Cocksfoot grass, Orchard grass

Dactylis glomerata.

Meadow fescue

Festuca elatior.

Rye-grass (perennial rye grass)

Lolium perenne.

Common reed (common reed grass)

Phragmites communis.

Meadow grass, Kentucky blue (June grass)

Poa pratensis.

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

Western ragweed

Ambrosia psilostachya.

False ragweed

Ambrosia acanthicarpa

(

Franseria acanthicarpa

Wormwood

Artemisia absinthium

Artemisia annua.

Mugwort

Artemisia vulgaris.

Marguerite, ox-eye daisy

Chrysanthemum leucanthemum.

Dandelion

Taraxacum vulgare

Taraxacum officinale.

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

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

Box-elder (Maple)

Acer negundo

Acer saccharum.

Gray alder, speckled alder (alder)

Alnus incana.

Hazel, hazelnut

Corylus avellana

Corylus americana.

American beech (beech)

Fagus grandifolia

(

Fagus americana

Mountain juniper, Mountain cedar

Juniperus ashei

(

Juniperus sabinoides

Elm

Ulmus americana.

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

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

Penicillium chrysogenum

(

Penicillium notatum

)

Penicillium chrysogenum

(

Penicillium notatum

Cladosporium herbarum

(

Hormodendrum

)

Cladosporium herbarum

(

Hormodendrum

Aspergillus fumigatus

Aspergillus fumigatus.

Mucor racemosus

Mucor racemosus.

Candida albicans

Candida albicans.

Botrytis cinerea

Botrytis cinerea.

Drechslera halodes

(

Setomelanomma rostrata, Helminthosporium halodes, Helminthosporium interseminatum

)

Drechslera halodes

(

Setomelanomma rostrata, Helminthosporium halodes.

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 nigrum

m15

Trichoderma viride

Trichoderma viride.

m16

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

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 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

Guinea pig epithelium

Cavia porcellus.

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

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

Greer Labs., Inc

NA.

Hollister-Stier Labs

NA.

Japan

NA.

Venoms & Insects

Midge

Chironomus yoshimatsui.

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

Cotton, crude fibers

Gossypium

spp.

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

Ascaris

Ascaris suum.

Echinococcus

Echinococcus granulosus.

Schistosoma

Schistosoma mansoni.

Anisakis (Herring Worm)

Anisakis simplex

(

Anisakis

spp.).

Toxocara canis

Toxocara canis.

p10

Ani s 3.0101

Anisakis simplex

(

Anisakis

spp.).

p11

Ani s 1

Anisakis simplex

(

Anisakis

spp.).

Occupational

Threshing dust

NA.

Flax

NA.

Hay Dust

NA.

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

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, 360

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, 360

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, 360

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.

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, 360

, 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, 360

, 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, 360

, 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, 360

, 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, 360

, 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, 360

, 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, 360

, 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.

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.

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

§ 886.4335

Operating headlamp.

(b)

Classification.

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, 360

, 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, 360

, 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, 360

, 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.

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

BILLING CODE 4164-01-P

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.