2019-27394. 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: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

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

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

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

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

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

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

II. Criteria for Exemption

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

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

III. Limitations on Exemptions

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

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

IV. Analysis of Environmental Impact

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

V. Paperwork Reduction Act of 1995

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

List of Subjects

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

• Medical devices

21 CFR Part 864

• Blood
• Medical devices
• Packaging and Containers

21 CFR Part 866

• Biologics
• Laboratories
• Medical devices

21 CFR Part 886

• Medical devices
• Ophthalmic goods and services

21 CFR Part 892

• Medical devices
• Radiation protection
• X-rays

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

PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

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

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

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

§ 862.1020

Acid phosphatase (total or prostatic) test system.

* * * * *

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

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

§ 862.1090

Angiotensin converting enzyme (A.C.E.) test system.

* * * * *

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

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

§ 862.1100

Aspartate amino transferase (AST/SGOT) test system.

* * * * *

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

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

§ 862.1150

Calibrator.

* * * * *

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

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

§ 862.1345

Glucose test system.

* * * * *

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

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

§ 862.1350

Continuous glucose monitor secondary display.

* * * * *

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

* * * * *

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

§ 862.1410

Iron (non-heme) test system.

* * * * *

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

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

§ 862.1415

Iron-binding capacity test system.

* * * * *

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

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

§ 862.1445

Lactate dehydrogenase isoenzymes test system.

* * * * *

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

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

§ 862.1509

Methylmalonic acid (nonquantitative) test system.

* * * * *

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

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

§ 862.1580

Phosphorous (inorganic) test system.

* * * * *

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

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

§ 862.1660

Quality control material (assayed and unassayed).

* * * * *

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

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

§ 862.1685

Thyroxine-binding globulin test system.

* * * * *

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

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

§ 862.1700

Total thyroxine test system.

* * * * *

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

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

§ 862.1775

Uric acid test system.

* * * * *

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

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

§ 862.2265

High throughput genomic sequence analyzer for clinical use.

* * * * *

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

* * * * *

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

§ 862.2570

Instrumentation for clinical multiplex test systems.

* * * * *

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

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

§ 862.3050

Breath-alcohol test system.

* * * * *

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

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

§ 862.3100

Amphetamine test system.

* * * * *

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

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

§ 862.3150

Barbiturate test system.

* * * * *

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

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

§ 862.3170

Benzodiazepine test system.

* * * * *

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

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

§ 862.3200

Clinical toxicology calibrator.

* * * * *

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

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

§ 862.3220

Carbon monoxide test system.

* * * * *

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

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

§ 862.3240

Cholinesterase test system.

* * * * *

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

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

§ 862.3250

Cocaine and cocaine metabolite test system.

* * * * *

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

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

§ 862.3270

Codeine test system.

* * * * *

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

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

§ 862.3280

Clinical toxicology control material.

* * * * *

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

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

§ 862.3580

Lysergic acid diethylamide (LSD) test system.

* * * * *

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

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

§ 862.3610

Methamphetamine test system.

* * * * *

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

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

§ 862.3620

Methadone test system.

* * * * *

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

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

§ 862.3630

Methaqualone test system.

* * * * *

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

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

§ 862.3640

Morphine test system.

* * * * *

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

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

§ 862.3650

Opiate test system.

* * * * *

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

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

§ 862.3700

Propoxyphene test system.

* * * * *

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

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

§ 862.3870

Cannabinoid test system.

* * * * *

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

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

§ 862.3910

Tricyclic antidepressant drugs test system.

* * * * *

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

PART 864—HEMATOLOGY AND PATHOLOGY DEVICES

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

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

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

§ 866.2900

Microbiological specimen collection and transport device.

* * * * *

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

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

§ 866.3395

Norovirus serological reagents.

* * * * *

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

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

§ 866.5210

Ceruloplasmin immunological test system.

* * * * *

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

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

§ 866.5470

Hemoglobin immunological test system.

* * * * *

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

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

§ 866.5620

Alpha-2-macroglobulin immunological test system.

* * * * *

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

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

§ 866.5630

Beta-2-microglobulin immunological test system.

* * * * *

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

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

§ 866.5750

Radioallergosorbent (RAST) immunological test system.

* * * * *

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

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

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

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

§ 866.5910

Quality control material for cystic fibrosis nucleic acid assays.

* * * * *

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

PART 868—ANESTHESIOLOGY DEVICES

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

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

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

§ 872.1720

Pulp tester.

* * * * *

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

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

§ 872.3260

Cavity varnish.

* * * * *

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

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

§ 872.3300

Hydrophilic resin coating for dentures.

* * * * *

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

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

§ 872.3540

OTC denture cushion or pad.

* * * * *

(b) * * *

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

* * * * *

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

§ 872.3560

OTC denture reliner.

* * * * *

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

* * * * *

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

§ 872.3590

Preformed plastic denture tooth.

* * * * *

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

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

§ 872.3600

Partially fabricated denture kit.

* * * * *

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

* * * * *

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

§ 872.3890

Endodontic stabilizing splint.

* * * * *

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

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

§ 872.5550

Teething ring.

* * * * *

(b) * * *

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

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

§ 872.6770

Cartridge syringe.

* * * * *

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

PART 874—EAR, NOSE, AND THROAT DEVICES

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

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

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

§ 886.1120

Ophthalmic camera.

* * * * *

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

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

§ 886.1250

Euthyscope.

* * * * *

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

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

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

§ 886.1570

Ophthalmoscope.

* * * * *

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

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

§ 886.1780

Retinoscope.

* * * * *

(b) * * *

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

* * * * *

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

§ 886.1850

AC-powered slitlamp biomicroscope.

* * * * *

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

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

§ 886.1945

Transilluminator.

* * * * *

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

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

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

§ 886.3320

Eye sphere implant.

* * * * *

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

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

§ 886.4070

Powered corneal burr.

* * * * *

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

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

§ 886.4150

Vitreous aspiration and cutting instrument.

* * * * *

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

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

§ 886.4250

Ophthalmic electrolysis unit.

* * * * *

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

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

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

§ 886.4335

Operating headlamp.

* * * * *

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

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

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

§ 886.4400

Electronic metal locator.

* * * * *

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

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

§ 886.4440

AC-powered magnet.

* * * * *

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

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

§ 886.4790

Ophthalmic sponge.

* * * * *

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

PART 888—ORTHOPEDIC DEVICES

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

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

Footnotes

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

2.  Available at: https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents/​procedures-class-ii-device-exemptions-premarket-notification-guidance-industry-and-cdrh-staff.