# Radionuclide brachytherapy source.
**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: *[email protected].*
**SUPPLEMENTARY INFORMATION:**
**I. Background**
The Cures Act (Pub. L. 114-255) was signed into law on December 13, 2016. Under the Cures Act, section 3054 amended section 510(l) and (m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360(l) and (m)). As amended, section 510(l)(2) of the FD&C Act requires FDA to identify through publication in the *Federal Register* , any type of class I device that the Agency determines no longer requires a report under section 510(k) of the FD&C Act to provide reasonable assurance of safety and effectiveness. FDA shall publish this determination within 120 days of the date of enactment of the Cures Act and at least once every 5 years thereafter, as FDA determines appropriate. Further, section 510(l)(2) provides that upon the date of publication of the Agency's determination in the *Federal Register* , a 510(k) will no longer be required for these devices and the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption.
As amended, section 510(m)(1)(A) of the FD&C Act provides that, within 90 days after enactment of the Cures Act and at least once every 5 years thereafter, FDA shall publish in the *Federal Register* a notice containing a list of each type of class II device that FDA determines no longer requires a report under section 510(k) of the FD&C Act to provide reasonable assurance of safety and effectiveness. This notice shall provide at least a 60-day comment period. Within 210 days of enactment of the Cures Act, FDA shall publish in the *Federal Register* a list representing its final determination regarding exemption of devices that were contained in the proposed list published under 510(m)(1)(A) of the FD&C Act. Further, section 510(m)(3) of the FD&C Act provides that upon the date of publication of the final list in the *Federal Register* , a 510(k) will no longer be required for these devices and the classification regulation applicable to each such device shall be deemed amended to incorporate such exemption.
In the *Federal Register* of April 13, 2017 (82 FR 17841), in accordance with the amendments to 510(l)(2), FDA issued a notice of final determination to exempt a list of class I devices from premarket notification requirements under section 510(k) of the FD&C Act, subject to certain limitations. In the *Federal Register* of March 14, 2017 (82 FR 13609), in accordance with the amendments to 510(m)(1)(A), FDA issued a notice proposing to exempt a list of class II devices from premarket notification requirements under section 510(k) of the FD&C Act, subject to certain limitations. After a 60-day comment period, in the *Federal Register* of July 11, 2017 (82 FR 31976), FDA issued a notice of final determination to exempt class II devices provided in the proposed list. Through this action, FDA is now amending the codified language for each listed classification regulation to reflect final determinations for these class I and class II exemptions. [^1]
[^1] FDA notes that the “ACTION” caption for this final order is styled as “Final amendment; final order,” rather than “Final order.” Beginning in December 2019, this editorial change was made to indicate that the document “amends” the Code of Federal Regulations. The change was made in accordance with the Office of Federal Register's (OFR) interpretations of the Federal Register Act (44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and parts 21 and 22), and the Document Drafting Handbook.
Following publication of the notices, FDA determined that it is unnecessary to update three classification regulations (21 CFR 872.4565, 21 CFR 878.4014, and 21 CFR 880.6320) included in the class I notice, 82 FR 17841. Five product codes corresponding to these three classification regulations (EGI and EIB (21 CFR 872.4565), OVR (21 CFR 878.4014), KZF and PEQ (21 CFR 880.6320)) were identified for exemption in 82 FR 17841; however, the corresponding classification regulations were already class I, exempt from premarket notification procedures in subpart E of part 807 (21 CFR part 807, subpart E) subject to the limitations in the corresponding “.9” regulations ( *i.e.,* 21 CFR 872.9, 21 CFR 878.9 or 21 CFR 880.9); and, therefore, no revisions to the codified are necessary. Additionally, we determined that it is unnecessary to update 21 CFR 876.5820 included in the class II notice, 82 FR 13609. The product code within this classification regulation (FKI) was identified for exemption in 82 FR 13609. However, this device type is specifically identified within the class I paragraph of this classification regulation (21 CFR 876.5820(b)(2)) and already exempt from premarket notification procedures in subpart E of part 807 subject to the limitations in 21 CFR 876.9. Therefore, no revisions to the codified are necessary.
We are also making a revision to correct a misidentified classification regulation in 82 FR 31976. The notice incorrectly listed the classification regulation 21 CFR 868.1400 “Carbon dioxide gas analyzer” as corresponding with product code LLK; however, the correct classification regulation associated with product code LLK is 21 CFR 880.5780 “Medical Support Stocking”. Therefore, 21 CFR 868.1400 remains unchanged, and 21 CFR 880.5780(a)(2) is revised to reflect the exemption.
We are revising the name of one classification regulation, currently entitled “Urological clamp for males”, in response to FDA's exemption in 82 FR 17841. Part 876.5160 is currently entitled “Urological clamp for males,” which was previously exempt from premarket notification procedures “. . . Except when intended for internal use or use on females . . .”. In 82 FR 17841, we exempted product code MNG, “External Urethral Occluder, Urinary Incontinence-Control, Female” and removed the current limitation language regarding “use on females.” Therefore, FDA is revising the name of the classification regulation to read “Urological clamp” to ensure clarity.
**II. Criteria for Exemption**
As amended by the Cures Act, section 510(l) now has two provisions, 510(l)(1) and (2). Under 510(1)(1), a class I device is exempt from the premarket notification requirements under section 510(k) of the FD&C Act, unless the device is intended for a use which is of substantial importance in preventing impairment of human health or it presents a potential unreasonable risk of illness or injury. Based on these criteria, FDA evaluated all class I devices to determine which device types should be exempt from premarket notification requirements.
For class II devices, there are a number of factors FDA may consider to determine whether a 510(k) is necessary to provide reasonable assurance of the safety and effectiveness of a class II device. These factors are discussed in the January 21, 1998, *Federal Register* notice (63 FR 3142) and subsequently in the guidance we issued on February 19, 1998, entitled “Procedures for Class II Device Exemptions From Premarket Notification, Guidance for Industry and CDRH Staff ”. [^2]
[^2] Available at: *https://www.fda.gov/regulatory-information/search-fda-guidance-documents/procedures-class-ii-device-exemptions-premarket-notification-guidance-industry-and-cdrh-staff.*
**III. Limitations on Exemptions**
Although FDA exempted the types of class I and class II devices from the premarket notification requirements under section 510(k) of the FD&C Act in accordance with the provisions under 510(l) and (m), an exemption from the requirement of premarket notification does not mean the device is exempt from any other statutory or regulatory requirements, unless such exemption is explicitly provided by order or regulation. FDA's determination that premarket notification is unnecessary to provide a reasonable assurance of safety and effectiveness is based, in part, on the assurance of safety and effectiveness that other regulatory controls, such as current good manufacturing practice requirements, provide.
In addition to being subject to the general limitations to the exemptions found in 21 CFR 862.9 to 892.9, FDA has also partially limited some exemptions from premarket notification requirements to specific devices within the listed device type. In such situations where a partial exemption limitation has been identified, FDA has determined that premarket notification is necessary to provide a reasonable assurance of safety and effectiveness for these devices.
**IV. Analysis of Environmental Impact**
The Agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
**V. Paperwork Reduction Act of 1995**
This final order refers to previously approved FDA collections of information. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR parts 801 and 809, regarding labeling, have been approved under OMB control number 0910-0485; and the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073.
**List of Subjects**
Medical devices.
Blood, Medical devices, Packaging and Containers.
Biologics, Laboratories, Medical devices.
Medical devices, Ophthalmic goods and services.
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**
**21 CFR Part 862**
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.
**21 CFR Part 862**
2. In § 862.1020, revise paragraph (b) to read as follows:
§ 862.1020
(b) *Classification.* Class II (special 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.
**21 CFR Part 862**
3. In § 862.1090, revise paragraph (b) to read as follows:
§ 862.1090
(b) *Classification.* Class II (special 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.
**21 CFR Part 862**
4. In § 862.1100, revise paragraph (b) to read as follows:
§ 862.1100
(b) *Classification.* Class II (special 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.
**21 CFR Part 862**
5. In § 862.1150, revise paragraph (b) to read as follows:
§ 862.1150
(b) *Classification.* Class II (special 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.
**21 CFR Part 862**
6. In § 862.1345, revise paragraph (b) to read as follows:
§ 862.1345
(b) *Classification.* Class II (special 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.
**21 CFR Part 862**
7. In § 862.1350, revise paragraph (b) introductory text to read as follows:
§ 862.1350
(b) *Classification.* Class II (special 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:
**21 CFR Part 862**
8. In § 862.1410, revise paragraph (b) to read as follows:
§ 862.1410
(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.
**21 CFR Part 862**
9. In § 862.1415, revise paragraph (b) to read as follows:
§ 862.1415
(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.
**21 CFR Part 862**
10. In § 862.1445, revise paragraph (b) to read as follows:
§ 862.1445
(b) *Classification.* Class II (special 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.
**21 CFR Part 862**
11. In § 862.1509, revise paragraph (b) to read as follows:
§ 862.1509
(b) *Classification.* Class II (special 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.
**21 CFR Part 862**
12. In § 862.1580, revise paragraph (b) to read as follows:
§ 862.1580
(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.
**21 CFR Part 862**
13. In § 862.1660, revise paragraph (b) to read as follows:
§ 862.1660
(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.
**21 CFR Part 862**
14. In § 862.1685, revise paragraph (b) as follows:
§ 862.1685
(b) *Classification.* Class II (special 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.
**21 CFR Part 862**
15. In § 862.1700, revise paragraph (b) as follows:
§ 862.1700
(b) *Classification.* Class II (special 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.
**21 CFR Part 862**
16. In § 862.1775, revise paragraph (b) to read as follows:
§ 862.1775
(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.
**21 CFR Part 862**
17. In § 862.2265, revise paragraph (b) introductory text to read as follows:
§ 862.2265
(b) *Classification.* Class II (special 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:
**21 CFR Part 862**
18. In § 862.2570, revise paragraph (b) to read as follows:
§ 862.2570
(b) *Classification.* Class II (special 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.
**21 CFR Part 862**
19. In § 862.3050, revise paragraph (b) to read as follows:
§ 862.3050
(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.
**21 CFR Part 862**
20. In § 862.3100, revise paragraph (b) to read as follows:
§ 862.3100
(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 CFR Part 862**
21. In § 862.3150, revise paragraph (b) to read as follows:
§ 862.3150
(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).
**21 CFR Part 862**
22. In § 862.3170, revise paragraph (b) to read as follows:
§ 862.3170
(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).
**21 CFR Part 862**
23. In § 862.3200, revise paragraph (b) to read as follows:
§ 862.3200
(b) *Classification.* Class II (special 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.
**21 CFR Part 862**
24. In § 862.3220, revise paragraph (b) to read as follows:
§ 862.3220
(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.
**21 CFR Part 862**
25. In § 862.3240, revise paragraph (b) to read as follows:
§ 862.3240
(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.
**21 CFR Part 862**
26. In § 862.3250, revise paragraph (b) to read as follows:
§ 862.3250
(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).
**21 CFR Part 862**
27. In § 862.3270, revise paragraph (b) to read as follows:
§ 862.3270
(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).
**21 CFR Part 862**
28. In § 862.3280, revise paragraph (b) to read as follows:
§ 862.3280
(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.
**21 CFR Part 862**
29. In § 862.3580, revise paragraph (b) to read as follows:
§ 862.3580
(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).
**21 CFR Part 862**
30. In § 862.3610, revise paragraph (b) to read as follows:
§ 862.3610
(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).
**21 CFR Part 862**
31. In § 862.3620, revise paragraph (b) to read as follows:
§ 862.3620
(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).
**21 CFR Part 862**
32. In § 862.3630, revise paragraph (b) to read as follows:
§ 862.3630
(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).
**21 CFR Part 862**
33. In § 862.3640, revise paragraph (b) to read as follows:
§ 862.3640
(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).
**21 CFR Part 862**
34. In § 862.3650, revise paragraph (b) to read as follows:
§ 862.3650
(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).
**21 CFR Part 862**
35. In § 862.3700, revise paragraph (b) to read as follows:
§ 862.3700
(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).
**21 CFR Part 862**
36. In § 862.3870, revise paragraph (b) to read as follows:
§ 862.3870
(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).
**21 CFR Part 862**
37. In § 862.3910, revise paragraph (b) to read as follows:
§ 862.3910
(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**
**21 CFR Part 864**
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.
**21 CFR Part 864**
39. In § 864.5400, revise paragraph (b) to read as follows:
§ 864.5400
(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.
**21 CFR Part 864**
40. In § 864.5425, revise paragraph (b) to read as follows:
§ 864.5425
(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.
**21 CFR Part 864**
41. In § 864.6550, revise paragraph (b) to read as follows:
§ 864.6550
(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.
**21 CFR Part 864**
42. In § 864.7040, revise paragraph (b) to read as follows:
§ 864.7040
(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.
**21 CFR Part 864**
43. In § 864.7275, revise paragraph (b) to read as follows:
§ 864.7275
(b) *Classification.* Class II (special 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.
**21 CFR Part 864**
44. In § 864.7300, revise paragraph (b) to read as follows:
§ 864.7300
(b) *Classification.* Class II (special 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.
**21 CFR Part 864**
45. In § 864.7340, revise paragraph (b) to read as follows:
§ 864.7340
(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.
**21 CFR Part 864**
46. In § 864.7375, revise paragraph (b) to read as follows:
§ 864.7375
(b) *Classification.* Class II (special 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.
**21 CFR Part 864**
47. In § 864.7415, revise paragraph (b) to read as follows:
§ 864.7415
(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.
**21 CFR Part 864**
48. In § 864.7455, revise paragraph (b) to read as follows:
§ 864.7455
(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.
**21 CFR Part 864**
49. In § 864.7500, revise paragraph (b) to read as follows:
§ 864.7500
(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.
**21 CFR Part 864**
50. In § 864.7720, revise paragraph (b) to read as follows:
§ 864.7720
(b) *Classification.* Class II (special 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.
**21 CFR Part 864**
51. In § 864.7735, revise paragraph (b) to read as follows:
§ 864.7735
(b) *Classification.* Class II (special 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.
**21 CFR Part 864**
52. In § 864.8150, revise paragraph (b) to read as follows:
§ 864.8150
(b) *Classification.* Class II (special 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.
**21 CFR Part 864**
53. In § 864.8165, revise paragraph (b) to read as follows:
§ 864.8165
(b) *Classification.* Class II (special 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.
**21 CFR Part 864**
54. In § 864.8175, revise paragraph (b) to read as follows:
§ 864.8175
(b) *Classification.* Class II (special 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.
**21 CFR Part 864**
55. In § 864.8185, revise paragraph (b) to read as follows:
§ 864.8185
(b) *Classification.* Class II (special 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.
**21 CFR Part 864**
56. In § 864.8625, revise paragraph (b) to read as follows:
§ 864.8625
(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.
**21 CFR Part 864**
57. In § 864.9400, revise paragraph (b) to read as follows:
§ 864.9400
(b) *Classification.* Class II (special 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**
**21 CFR Part 866**
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.
**21 CFR Part 866**
59. In § 866.2900, revise paragraph (b) to read as follows:
§ 866.2900
(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.
**21 CFR Part 866**
60. In § 866.3395, revise paragraph (b) to read as follows:
§ 866.3395
(b) *Classification.* Class II (special 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.
**21 CFR Part 866**
61. In § 866.5210, revise paragraph (b) to read as follows:
§ 866.5210
(b) *Classification.* Class II (special 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.
**21 CFR Part 866**
62. In § 866.5470, revise paragraph (b) to read as follows:
§ 866.5470
(b) *Classification.* Class II (special 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.
**21 CFR Part 866**
63. In § 866.5620, revise paragraph (b) to read as follows:
§ 866.5620
(b) *Classification.* Class II (special 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.
**21 CFR Part 866**
64. In § 866.5630, revise paragraph (b) to read as follows:
§ 866.5630
(b) *Classification.* Class II (special 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.
**21 CFR Part 866**
65. In § 866.5750, revise paragraph (b) to read as follows:
§ 866.5750
(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.
| Allergen code | Allergen product | Source |
| --- | --- | --- |
| | | |
| g1 | Sweet vernal grass | |
| g3 | Cocksfoot grass, Orchard grass | |
| g4 | Meadow fescue | |
| g5 | Rye-grass (perennial rye grass) | |
| g7 | Common reed (common reed grass) | |
| g8 | Meadow grass, Kentucky blue (June grass) | |
| g9 | Redtop, Bentgrass | ,
(
). |
| g11 | Brome grass | |
| g12 | Cultivated rye (cultivated rye grass) | |
| g13 | Velvet grass | |
| g14 | Cultivated oat (cultivated oat grass) | |
| g15 | Cultivated wheat (cultivated wheat grass) | (
spp.). |
| g16 | Meadow foxtail (meadow foxtail grass) | |
| g17 | Bahia grass | |
| g24 | Wheat grass, Western | (
). |
| g30 | Bluegrass, annual | |
| g70 | Wild rye grass | |
| g71 | Canary grass | |
| g201 | Barley, cultivated | |
| g202 | Maize, corn (cultivated corn) | |
| g203 | Salt grass | |
| g204 | False oat-grass | |
| g216 | Cyn d 1 | |
| g701 | Phl p 1.0102, Phl p 5.0101 | |
| g702 | Phl p 7.0101 | |
| g703 | Phl p 12.0101 | |
| | | |
| w2 | Western ragweed | |
| w4 | False ragweed | (
). |
| w5 | Wormwood | |
| w6 | Mugwort | |
| w7 | Marguerite, ox-eye daisy | |
| w8 | Dandelion | , |
| w9 | Plantain (English), Ribwort | |
| w10 | Goosefoot, lamb's quarters | |
| w11 | Saltwort (prickly), Russian thistle | (
). |
| w12 | Goldenrod | (
spp.). |
| w13 | Cocklebur, common | |
| w14 | Common pigweed (rough pigweed) | |
| w15 | Scale, Lenscale | |
| w16 | Rough marsh elder | , |
| w17 | Firebush (Kochia) | |
| w18 | Sheep sorrel | |
| w19 | Wall pellitory | |
| w20 | Nettle (Common stinging nettle) | |
| w21 | Wall pellitory | |
| w22 | Japanese hop (careless weed) | (
). |
| w23 | Yellow dock, Yellow dockweed | |
| w24 | Spiny pigweed | |
| w27 | Carnation | spp. |
| w28 | Rose | |
| w33 | Clover | |
| w35 | Mexican tea | |
| w36 | Rabbit bush | (
). |
| w37 | Salt bush, annual | |
| w39 | Water hemp, Western | (
). |
| w41 | Burrobrush | |
| w42 | Poverty weed | |
| w43 | Common sagebrush | |
| w45 | Alfalfa | |
| w46 | Dog fennel | |
| w53 | Geranium | spp. |
| w67 | Groundsel bush | |
| w69 | Iodine bush | |
| w70 | Ragweed, slender | |
| w75 | Wing scale (wingscale) | |
| w82 | Careless weed | , |
| w90 | Japanese hop | (
). |
| w203 | Rape (rape pollen) | |
| w204 | Sunflower | |
| w206 | Camomile | |
| w207 | Lupin | spp. |
| w210 | Sugar-beet | |
| w211 | Par j 2.0101 | |
| w231 | Art v 1 | (Mugwort). |
| w232 | Sal k 1 | |
| w233 | Art v 3 | (LTP, Mugwort). |
| w234 | Pla l 1 | |
| w235 | Che a 1.0101 | |
| w236 | Mer a 1.0101 | |
| a753 | Art v 1 | (Mugwort weed). |
| | | |
| t1 | Box-elder (Maple) | , |
| t2 | Gray alder, speckled alder (alder) | |
| t4 | Hazel, hazelnut | , |
| t5 | American beech (beech) | (
). |
| t6 | Mountain juniper, Mountain cedar | (
). |
| t8 | Elm | |
| t9 | Olive | |
| t10 | Walnut | , |
| t11 | Maple leaf sycamore, London plane, Plane tree | |
| t61 | Sycamore | |
| t12 | Willow | , |
| t14 | Cottonwood (Eastern Cottonwood/Black Cottonwood) | |
| t15 | White ash | |
| t16 | White pine | |
| t18 | Eucalyptus, gum-tree | (
spp.). |
| t19/t26 | Acacia | (
spp.). |
| t20 | Mesquite | |
| t21 | Melaleuca, cajeput tree | (
). |
| t22 | Pecan, hickory | (
). |
| t23 | Italian/Mediterranean/funeral cypress | |
| t24 | Japanese cypress | (
spp.). |
| t25 | Ash | |
| t27 | Maple, red | |
| t29 | Acacia | spp. |
| t30 | Birch, white | |
| t32 | Willow, black | |
| t33 | Ash, Arizona | |
| t35 | Cedar, salt | |
| t37 | Bald cypress (white bald cypress) | |
| t38 | Elm, Chinese/Siberian | |
| t40 | Hazelnut tree | |
| t41 | White hickory | (
). |
| t42 | Oak, red | |
| t43 | Loblolly pine | |
| t44 | Hackberry | |
| t45 | Cedar elm | |
| t47 | Juniper, one seed | |
| t48 | Pine, lodgepole | |
| t49 | Pine, ponderosa | |
| t50 | Beech, European | |
| t51 | Tree of Heaven | |
| t52 | Western white pine | |
| t54 | Russian olive | |
| t55 | Scotch broom | |
| t56 | Bayberry | |
| t57 | Red cedar | |
| t60 | Western juniper | |
| t61 | Sycamore | |
| t70 | Mulberry (white mulberry) | |
| t71 | Red mulberry | |
| t72 | Queen palm | |
| t73 | Australian pine | |
| t77 | Oak mix (red, white, black) | spp. |
| t80 | Japanese cypress | |
| t81 | Japanese alder | |
| t83 | Mango tree | |
| t90 | Walnut, black | |
| t96 | Poplar, white (poplar) | |
| t103/t218 | Virginia live oak (live oak) | |
| t105 | Pepper tree | |
| t110 | Orange tree | |
| t201 | Spruce, Norway spruce | (
). |
| t202 | Alder, smooth | spp.
(
). |
| t203 | Horse chestnut | |
| t205 | Elder | |
| t206 | Chestnut | |
| t207 | Douglas fir | (
). |
| t208 | Linden | |
| t209 | Horn beam | |
| t210 | Privet | |
| t211 | Sweet gum | |
| t212 | Cedar | |
| t213 | Pine | |
| t214 | Date palm | |
| t215 | Lilac | |
| t217 | Pepper tree | |
| t217 | Red alder | |
| t218 | Virginia live oak | |
| t218 | Bayberry (bayberry/sweet gale) | |
| t219 | Palo verde | |
| t219 | Red cedar | |
| t220 | Bet v 4 | (Birch). |
| t221 | Bet v 2.0101, Bet v 4 | (Birch). |
| t222 | Cypress (Arizona cypress) | |
| t223 | Oil palm | |
| t224 | Ole e 1 | |
| t225 | Bet v 6 | (Birch). |
| t226 | Cup a 1 | |
| t227 | Ole e 7 | |
| t228 | Aspen, quaking | |
| t229 | Eastern hemlock | |
| t230 | Redwood (sequoia) | |
| t232 | Pussy willow | |
| t240 | Ole e 9.0101 | |
| t241 | Pla a 1.0101 | |
| t242 | Pla a 2 | |
| t243 | Pla a 3.0101 | |
| t244 | Cor a 1.0103 | |
| t245 | Aln g 1.0101 | |
| t246 | Cry j 1 | |
| t280 | Locust tree | |
| t401 | Brazilian peppertree | |
| t402 | Mastic tree | |
| t404 | Tree of heaven | |
| t406 | Date palm | |
| a482 | Ole e 1 | (Olive Oil). |
| | | |
| d207 | Blo t 5.0101 | |
| d208 | Lep d 2.0101 | |
| | | |
| m1 | (
) | (
). |
| m2 | (
) | (
). |
| m3 | | |
| m4 | | |
| m5 | | |
| m7 | | |
| m8 | (
) | ( |
| m9 | (
) | (
). |
| m10 | | (
). |
| m11 | | |
| m12 | | |
| m13 | | |
| m14 | | (
). |
| m15 | | |
| m16 | | ,
(
). |
| m17 | | |
| m18 | | |
| m19 | | |
| m20 | | |
| m21 | | |
| m22 | | (
). |
| m23 | | |
| m24 | | (
). |
| m24 | spp | spp. |
| m25 | | |
| m25 | | |
| m26 | | |
| m26 | | |
| m27 | spp | spp. |
| m29 | | |
| m30 | | |
| m32 | | |
| m34 | | |
| m36 | | |
| m37 | | |
| m40 | | |
| m43 | | |
| m44 | | |
| m45 | | |
| m46 | | |
| m47 | | |
| m48 | | |
| m49 | | |
| m50 | | (
). |
| m51 | | |
| m53 | | (
). |
| m54 | | |
| m63 | | |
| m66 | | |
| m67 | | |
| m68 | | |
| m69 | | (
). |
| m70 | (
) | (
). |
| m71 | | spp. |
| m72 | | |
| m73 | | (
). |
| m80 | (
) | |
| m80 | spp | spp. |
| m81 | (
) | |
| m88 | | |
| m93 | | |
| m94 | | |
| m201 | (
) (Barley smut) | (
). |
| m202 | (
) | (
). |
| m203 | | |
| m204 | | |
| m205 | | |
| m207 | | |
| m208 | | |
| m209 | | (
). |
| m209 | | (
). |
| m210 | | |
| m211 | | |
| m211 | Oat smut | |
| m212 | | (
). |
| m212 | | |
| m213 | Bermuda grass smut | |
| m214 | Johnson grass smut | |
| m215 | Corn smut | |
| m218 | Asp f 1.0101 | |
| a3050 | Asp r 1 | |
| m219 | Asp f 2 | |
| m220 | Asp f 3.0101 | |
| m221 | Asp f 4 | |
| m222 | Asp f 6.0101 | |
| m223 | (
) | |
| m224 | (
) | |
| m226 | (
) | |
| m227 | spp. (
spp.) | spp. (
spp.). |
| m228 | | |
| m229 | Alt a 1.0101 | (
). |
| m230 | Alt a 6.0101 | (
). |
| m231 | Cla h 8.0101 | (
). |
| m300 | spp | spp. |
| m304 | | |
| m305 | | |
| m309 | | |
| m310 | | |
| m311 | | |
| m312 | | |
| | | |
| e6 | Guinea pig epithelium | |
| e7 | Pigeon droppings | , |
| e25 | Chicken serum | (
spp.). |
| e26 | Parrot serum | spp. |
| e62 | Camel | |
| e70 | Goose feathers | |
| e71 | Mouse epithelium | (
spp.). |
| e73 | Rat epithelium | |
| e74 | Rat urine proteins | , |
| e75 | Rat serum proteins | , |
| e76 | Mouse serum proteins | (
spp.). |
| e77 | Budgerigar droppings | |
| e78 | Budgerigar feathers | |
| e79 | Budgerigar serum proteins | |
| e80 | Goat epithelium | |
| e81 | Sheep epithelium | (
spp.). |
| e82 | Rabbit epithelium | (
spp.). |
| e83 | Swine epithelium | (
spp.). |
| e84 | Hamster epithelium | |
| e85 | Chicken feathers | (
spp.). |
| e86 | Duck feathers | |
| e87 | Rat epithelium, serum proteins, and urine proteins | |
| e88 | Mouse epithelium, serum proteins, and urine proteins (mouse) | (
spp.). |
| e89 | Turkey feathers | |
| e90 | Budgerigar serum proteins, feathers, and droppings | |
| e91 | Pigeon serum proteins, feathers, and droppings | ,
spp. |
| e92 | Parrot serum proteins, feathers, and droppings | spp. |
| e93 | Pigeon serum proteins | |
| e94 | Fel d 1.0101 | |
| a345 | Fel d 1 | |
| e98 | Parrot droppings | spp. |
| e101 | Can f 1.0101 | (
). |
| a174 | Can f 1 | (
). |
| e102 | Can f 2.0101 | (
). |
| e196 | Parakeet feathers | |
| e197 | Parakeet droppings | |
| e198 | Parakeet serum | |
| e199 | Canary bird serum | |
| e200 | Canary bird droppings | |
| e201 | Canary bird feathers (Canary feathers) | |
| e202 | Reindeer epithelium | |
| e203 | Mink epithelium | spp. |
| e204 | Bos d 6 | (
spp.). |
| e205 | Horse, serum proteins | (
spp.). |
| e206 | Rabbit, serum proteins | (
spp.). |
| e208 | Chinchilla epithelium | |
| e209 | Gerbil epithelium | |
| e210 | Fox epithelium | |
| e211 | Rabbit, urine proteins | (
spp.). |
| e212 | Swine, urine proteins | (
spp.). |
| e213 | Parrot feathers | spp. |
| e214 | Finch feathers | |
| e215 | Pigeon feathers | (
spp.),
spp. |
| e216 | Deer epithelium | |
| e217 | Ferret epithelium | |
| e218 | Chicken droppings | (
spp.). |
| e219 | Chicken, serum proteins | (
spp.). |
| e220 | Fel d 2, Cat serum albumin | |
| e221 | Can f 3 | (
) (
). |
| e222 | Swine serum albumin (Sus s PSA) | (
spp.). |
| e225 | Lovebird feathers | |
| e226 | Can f 5.0101 | |
| e227 | Equ c 1.0101 | |
| e228 | Fel d 4.0101 | |
| e230 | Equ c 3 | |
| e231 | Mus m 1 | |
| | | |
| f9 | Rice | |
| f12 | Pea (green pea) | |
| f15 | White bean | |
| f19 | Cayenne pepper | (
). |
| f21 | Sugar cane | |
| f22 | Raspberry | |
| f26 | Pork | (
spp.). |
| f29 | Watermelon | (
). |
| f31 | Carrot | |
| f32 | Oyster mushroom | |
| f33 | Orange | |
| f35 | Potato | |
| f43 | Mother's milk | |
| f44 | Strawberry | (
spp.). |
| f45 | Yeast, baker's | |
| f46 | Pepper, Red | |
| f47 | Garlic | |
| f48 | Onion | |
| f49 | Apple | (
spp.). |
| f51 | Bamboo shoot | |
| f52 | Cacao/chocolate | |
| f54 | Sweet potato | |
| f55 | Common millet | |
| f56 | Foxtail millet | |
| f57 | Japanese millet | |
| f58 | Pacific squid | |
| f59 | Octopus | (
spp.). |
| f63 | Kefir | NA. |
| f67 | Parmesan cheese | NA. |
| f81 | Cheese, cheddar type | NA. |
| f82 | Cheese, mold type | NA. |
| f83 | Chicken | (
spp.). |
| f86 | Parsley | |
| f87 | Melon | |
| f88 | Mutton (lamb) | (
spp.). |
| f90 | Malt | |
| f92 | Banana | spp. |
| f93 | Cacao | |
| f94 | Pear | (
spp.). |
| f97 | Yam | spp. |
| f97 | Chamomile tea | |
| f98 | Gliadin | (
spp.). |
| f102 | Cantaloupe | |
| f105 | Chocolate | |
| f109 | Cottonseed | |
| f110 | Giant radish | |
| f118 | Zucchini | |
| f119 | Radish | |
| f120 | Venison | |
| f121 | Pinto bean | |
| f122 | Cheese, American | NA. |
| f127 | Black-eyed pea | |
| f131 | Black Olive | |
| f136 | Red beet | |
| f139 | Goat's Cheese | |
| f140 | Bran | NA. |
| f141 | Corn (vegetables) | |
| f152 | Green bell pepper | |
| f155 | Brewer's yeast | |
| f157 | Duck | |
| f158 | Goose | |
| f160 | Camembert cheese | NA. |
| f162 | Nectarine | |
| f163 | Kohlrabi | |
| f65 | Perch | |
| f166 | Leek | |
| f170 | Cheese (Switzerland) (Swiss cheese) | NA. |
| f174 | Fig | |
| f177 | Cranberry | |
| f179 | Raisin | spp. |
| f182 | Lima bean | |
| f198 | Flaxseed (bruised grain) | |
| f199 | Untreated native milk | (
spp.). |
| f208 | Lemon | |
| f209 | Grapefruit | |
| f210 | Pineapple | |
| f211 | Blackberry | |
| f212 | Mushroom (champignon) | (
spp.). |
| f213 | Rabbit | (
spp.). |
| f214 | Spinach | |
| f215 | Lettuce | |
| f216 | Cabbage | |
| f217 | Brussels sprouts | |
| f218 | Paprika, sweet pepper | |
| f219 | Fennel seed | |
| f219 | Sage | |
| f220 | Cinnamon | spp. |
| f221 | Coffee | spp. |
| f222 | Tea | |
| f223 | Green olive | |
| f225 | Summer squash, pumpkin | |
| f225 | Pumpkin | |
| f226 | Pumpkin seed | |
| f227 | Sugar-beet seed | |
| f229 | Safflower Seed | |
| f231 | Milk, boiled | (
spp.). |
| f234 | Vanilla | |
| f237 | Apricot | |
| f241 | Gouda cheese | NA. |
| f242 | Cherry | |
| f244 | Cucumber | |
| f246 | Guar, guar gum | |
| f247 | Honey | NA. |
| f248 | Rosemary | |
| f254 | Plaice | |
| f255 | Plum | , |
| f258 | Squid | spp. |
| f259 | Grape | (
spp.). |
| f260 | Broccoli | (
). |
| f261 | Asparagus | |
| f262 | Aubergine, eggplant | |
| f263 | Green pepper | , |
| f264 | Eel | |
| f265 | Caraway | |
| f265 | Cumin | |
| f266 | Mace | |
| f267 | Cardamon | |
| f268 | Clove | |
| f269 | Basil | |
| f270 | Ginger | |
| f271 | Anise | |
| f272 | Tarragon | |
| f273 | Thyme | |
| f274 | Marjoram | |
| f275 | Lovage | |
| f276 | Fennel, fresh | |
| f277 | Dill | |
| f278 | Bay leaf | |
| f279 | Chili pepper | |
| f280 | Black pepper | |
| f281 | Curry (Santa Maria) | NA. |
| f282 | Nutmeg | |
| f283 | Oregano | |
| f284 | Turkey meat | |
| f285 | Elk/moose meat | spp. |
| f286 | Mare's milk | (
spp.). |
| f287 | Red kidney bean | |
| f288 | Blueberry | (
spp.). |
| f289 | Date | |
| f291 | Cauliflower | |
| f292 | Guava | |
| f293 | Papaya | |
| f294 | Passion fruit, Maracuja | (
spp.). |
| f295 | Carambola | |
| f296 | Carob | |
| f297 | Gum Arabic | (
spp.). |
| f298 | Tragacanth | spp. |
| f299 | Sweet chestnut (chestnut) | |
| f300 | Pinto bean | spp. |
| f301 | Persimmon (kaki fruit, sharon) | |
| f302 | Mandarin (tangerine, clementine, satsumas) | |
| f305 | Fenugreek | |
| f306 | Lime | |
| f307 | Hake | |
| f308 | Sardine (pilchard) | |
| f310 | Blue vetch | |
| f311 | Megrim | |
| f315 | Green bean | |
| f316 | Rape seed | |
| f317 | Coriander | |
| f318 | Jack fruit | |
| f319 | Beetroot | |
| f320 | Crayfish | |
| f321 | Horse meat | (
spp.). |
| f322 | Red currant | |
| f324 | Hop (fruit cone) | |
| f325 | Saffron | |
| f328 | Fig | |
| f329 | Watermelon | |
| f330 | Rose hip | spp. |
| f331 | Saffron | |
| f332 | Mint | |
| f333 | Linseed | |
| f336 | Jujube | |
| f336 | Wine vinegar | (
spp.). |
| f337 | Sole | |
| f337 | English sole | |
| f338 | Wine, white | (
spp.). |
| f339 | Allspice | |
| f339 | Wine, red | (
spp.). |
| f341 | Cranberry | , |
| f342 | Olive (black, fresh) | |
| f343 | Raspberry | |
| f344 | Sage | |
| f346 | Chives | |
| f347 | Quinoa | |
| f348 | Litchi | |
| f349 | Chum salmon roe | |
| f358 | Artichoke | |
| f360 | Yogurt | NA. |
| f368 | Black bass | (
). |
| f374 | Karaya gum | |
| f375 | Horseradish | |
| f377 | Maple syrup | NA. |
| f379 | Okra | |
| f382 | Beet, sugar | |
| f401 | Loquat | |
| f402 | Fig | |
| f403 | Brewer's yeast | |
| f405 | Mint | spp. |
| f406 | Arugula | |
| | | |
| h1 | Greer Labs., Inc | NA. |
| h2 | Hollister-Stier Labs | NA. |
| h6 | Japan | NA. |
| | | |
| i7 | Midge | |
| i8 | Moth | ,
spp. |
| i47 | Water flea | spp. |
| i49 | Deer fly | spp. |
| i51 | Black ant | |
| i54 | Flea mix (dog/cat), common flea | spp. |
| i71 | Mosquito | ,
spp.
spp. |
| i72 | Green nimitti | |
| i73 | Blood worm | ,
,
spp. |
| i75 | European hornet | |
| i76 | Berlin beetle | |
| i77 | European paper wasp | |
| i78 | Fly | |
| i80 | Bumblebee | |
| i201 | Horse bot fly | |
| i202 | Grain weevil | |
| i203 | Mediterranean flour moth | (
). |
| i204 | Horse fly | spp. |
| i205 | Bumblebee | |
| i208 | Api m 1.0101 | |
| a45 | Api m 1 | |
| i209 | Ves v 5.0101 | |
| a670 | Ves v 5 | |
| i210 | Pol d 5.0101 | |
| i211 | Ves v 1.0101 | |
| i213 | Api m 4 | |
| i214 | Api m 2 | |
| i215 | Api m 3 | |
| i216 | Api m 5 | |
| i217 | Api m 10 | |
| i220 | Bla g 1.0101 | |
| i221 | Bla g 2.0101 | |
| i222 | Bla g 5.0101 | |
| i223 | Bla g 7 | |
| a46 | Api m 2 | |
| | | |
| o1 | Cotton, crude fibers | spp. |
| o3 | Cotton (treated) | spp. |
| o70 | Seminal fluid | |
| o71 | | |
| o72 | crude extract customer specific | |
| o72 | Sperm-sediment | |
| o73 | crude extr. vector customer specific | |
| o74 | with vector customer specific | |
| o201 | Tobacco leaf, tobacco dust | |
| o202 | Artemia salina, fish feed | |
| o203 | Tetramin, fish feed | NA. |
| o207 | Daphnia, fish feed | spp. |
| o211 | Mealworm | |
| o212 | Streptavidin | |
| o213 | MBP (maltose binding protein) | |
| o214 | CCD; MUXF3 from bromelain | |
| o72 | Enterotoxin A (Sta a SEA) | |
| o73 | Enterotoxin B (Sta a SEB) | |
| | | |
| p1 | Ascaris | |
| p2 | Echinococcus | |
| p3 | Schistosoma | |
| p4 | Anisakis (Herring Worm) | (
spp.). |
| p5 | Toxocara canis | |
| p10 | Ani s 3.0101 | (
spp.). |
| p11 | Ani s 1 | (
spp.). |
| | | |
| k4 | Threshing dust | NA. |
| k5 | Flax | NA. |
| k7 | Hay Dust | NA. |
| k8 | Hop (hops) | |
| k12 | Grain mill dust | NA. |
| k14 | Kapok | NA. |
| k20 | Sheep's wool (treated) (wool) | (
spp.). |
| k21 | Sheep's wool (Untreated) | (
spp.). |
| k23 | Straw Dust | NA. |
| k33 | Oak | NA. |
| k70 | Green coffee bean | spp. |
| k71 | Castor bean | |
| k72 | Ispaghula | |
| k73 | Silk waste | NA. |
| k74 | Silk | |
| 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 | (
spp.). |
| k83 | Cotton seed | |
| k84 | Sunflower seed | |
| k85 | Chloramin T | NA. |
| k86 | Trimellitic anhydride, TMA | NA. |
| k87 | Asp o 21, alpha-amylase | |
| k89 | Orris root | |
| k99 | HSA (Human Serum Albumin) (Hom s HSA) | |
| k201 | Car p 1, Papain | |
| k202 | Ana c 2, Bromelain | |
| k204 | Maxatase | |
| k205 | Alcalase | spp. |
| k206 | Savinase, Protease 1 (Bac l Subtilisin) | spp. |
| k208 | Gal d 4, Lysozyme | (
spp.). |
| k209 | Hexahydrophtalic anhydrid | NA. |
| k210 | Maleic anhydride | NA. |
| k211 | Methyltetrahydrophtalic anhydrid | NA. |
| k212 | Abachi wood dust | |
| k213 | Pepsin (Sus s Pepsin) | (
spp.). |
| k213 | TCPA | NA. |
| k214 | Bougainvillea | spp. |
| k225 | Horse radish peroxidase (Arm r HRP) | |
| k226 | Ascorbate oxidase (Cuc p ascorbate oxidase) | |
| k301 | Flour dust | 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. |
**21 CFR Part 866**
66. In § 866.5910, revise paragraph (b) to read as follows:
§ 866.5910
(b) *Classification.* Class II (special 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**
**21 CFR Part 868**
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.
**21 CFR Part 868**
68. In § 868.1040, revise paragraph (b) to read as follows:
§ 868.1040
(b) *Classification.* Class II (special 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.
**21 CFR Part 868**
69. In § 868.2385, revise paragraph (b) to read as follows:
§ 868.2385
(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.
**21 CFR Part 868**
70. In § 868.2500, revise paragraph (b) to read as follows:
§ 868.2500
(b) *Classification.* Class II (special 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.
**21 CFR Part 868**
71. In § 868.2550, revise paragraph (b) to read as follows:
§ 868.2550
(b) *Classification.* Class II (special 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.
**21 CFR Part 868**
72. In § 868.5180, revise paragraph (b) to read as follows:
§ 868.5180
(b) *Classification.* Class II (special 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.
**21 CFR Part 868**
73. In § 868.6250, revise paragraph (b) to read as follows:
§ 868.6250
(b) *Classification.* Class II (special 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**
**21 CFR Part 870**
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.
**21 CFR Part 870**
75. In § 870.1330, revise paragraph (b) to read as follows:
§ 870.1330
(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.
**21 CFR Part 870**
76. In § 870.1390, revise paragraph (b) to read as follows:
§ 870.1390
(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.
**21 CFR Part 870**
77. In § 870.1650, revise paragraph (b) to read as follows:
§ 870.1650
(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.
**21 CFR Part 870**
78. In § 870.1875, revise paragraph (b)(2) to read as follows:
§ 870.1875
(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.
**21 CFR Part 870**
79. In § 870.2675, revise paragraph (b) to read as follows:
§ 870.2675
(b) *Classification.* Class II (special 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.
**21 CFR Part 870**
80. In § 870.2770, revise paragraph (b) to read as follows:
§ 870.2770
(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.
**21 CFR Part 870**
81. In § 870.4280, revise paragraph (b) to read as follows:
§ 870.4280
(b) *Classification.* Class II (special 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.
**21 CFR Part 870**
82. In § 870.4290, revise paragraph (b) to read as follows:
§ 870.4290
(b) *Classification.* Class II (special 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.
**21 CFR Part 870**
83. In § 870.4340, revise paragraph (b) to read as follows:
§ 870.4340
(b) *Classification.* Class II (special 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.
**21 CFR Part 870**
84. In § 870.4400, revise paragraph (b) to read as follows:
§ 870.4400
(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.
**21 CFR Part 870**
85. In § 870.4420, revise paragraph (b) to read as follows:
§ 870.4420
(b) *Classification.* Class II (special 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.
**21 CFR Part 870**
86. In § 870.4430, revise paragraph (b) to read as follows:
§ 870.4430
(b) *Classification.* Class II (special 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**
**21 CFR Part 872**
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.
**21 CFR Part 872**
88. In § 872.1720, revise paragraph (b) to read as follows:
§ 872.1720
(b) *Classification.* Class II (special 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.
**21 CFR Part 872**
89. In § 872.3260, revise paragraph (b) to read as follows:
§ 872.3260
(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.
**21 CFR Part 872**
90. In § 872.3300, revise paragraph (b) to read as follows:
§ 872.3300
(b) *Classification.* Class II (special 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.
**21 CFR Part 872**
91. In § 872.3540, revise paragraph (b)(2) introductory text to read as follows:
§ 872.3540
(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:
**21 CFR Part 872**
92. In § 872.3560, revise paragraph (b) introductory text to read as follows:
§ 872.3560
(b) *Classification.* Class II (special 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:
**21 CFR Part 872**
93. In § 872.3590, revise paragraph (b) to read as follows:
§ 872.3590
(b) *Classification.* Class II (special 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.
**21 CFR Part 872**
94. In § 872.3600, revise paragraph (b) introductory text to read as follows:
§ 872.3600
(b) *Classification.* Class II (special 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:
**21 CFR Part 872**
95. In § 872.3890, revise paragraph (b) to read as follows:
§ 872.3890
(b) *Classification.* Class II (special 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.
**21 CFR Part 872**
96. In § 872.5550, revise paragraph (b)(2) to read as follows:
§ 872.5550
(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.
**21 CFR Part 872**
97. In § 872.6770, revise paragraph (b) to read as follows:
§ 872.6770
(b) *Classification.* Class II (special 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**
**21 CFR Part 874**
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.
**21 CFR Part 874**
99. In § 874.1090, revise paragraph (b) to read as follows:
§ 874.1090
(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.
**21 CFR Part 874**
100. In § 874.1120, revise paragraph (b) to read as follows:
§ 874.1120
(b) *Classification.* Class II (special 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.
**21 CFR Part 874**
101. In § 874.1325, revise paragraph (b) to read as follows:
§ 874.1325
(b) *Classification.* Class II (special 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.
**21 CFR Part 874**
102. In § 874.3310, revise paragraph (b) to read as follows:
§ 874.3310
(b) *Classification.* Class II (special 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.
**21 CFR Part 874**
103. In § 874.3320, revise paragraph (b) to read as follows:
§ 874.3320
(b) *Classification.* Class II (special 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.
**21 CFR Part 874**
104. In § 874.3330, revise paragraph (b) to read as follows:
§ 874.3330
(b) *Classification.* Class II (special 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.
**21 CFR Part 874**
105. In § 874.3430, revise paragraph (b) to read as follows:
§ 874.3430
(b) *Classification.* Class II (special 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.
**21 CFR Part 874**
106. In § 874.3730, revise paragraph (b) to read as follows:
§ 874.3730
(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**
**21 CFR Part 876**
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.
**21 CFR Part 876**
108. In § 876.1500, revise paragraph (b)(1) to read as follows:
§ 876.1500
(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.
**21 CFR Part 876**
109. In § 876.4020, revise paragraph (b) to read as follows:
§ 876.4020
(b) *Classification.* Class II (special 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.
**21 CFR Part 876**
110. In § 876.4270, revise paragraph (b) to read as follows:
§ 876.4270
(b) *Classification.* Class II (special 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.
**21 CFR Part 876**
111. In § 876.4400, revise paragraph (b) to read as follows:
§ 876.4400
(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.
**21 CFR Part 876**
112. In § 876.4500, revise paragraph (b) to read as follows:
§ 876.4500
(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.
**21 CFR Part 876**
113. In § 876.4770, revise paragraph (b) to read as follows:
§ 876.4770
(b) *Classification.* Class II (special 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.
**21 CFR Part 876**
114. In § 876.5010, revise paragraph (b) to read as follows:
§ 876.5010
(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.
**21 CFR Part 876**
115. In § 876.5025, revise paragraph (b) introductory text to read as follows:
§ 876.5025
(b) *Classification.* Class II (special 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:
**21 CFR Part 876**
116. In § 876.5160, revise the section heading and paragraph (b) to read as follows:
§ 876.5160
(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.
**21 CFR Part 876**
117. In § 876.5365, revise paragraph (b) to read as follows:
§ 876.5365
(b) *Classification.* Class II (special 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.
**21 CFR Part 876**
118. In § 876.5520, revise paragraph (b)(1) to read as follows:
§ 876.5520
(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.
**21 CFR Part 876**
119. In § 876.5630, revise paragraph (b) to read as follows:
§ 876.5630
(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.
**21 CFR Part 876**
120. In § 876.5665, revise paragraph (b) to read as follows:
§ 876.5665
(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.
**21 CFR Part 876**
121. In § 876.5895, revise paragraph (b) to read as follows:
§ 876.5895
(b) *Classification.* Class II (special 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.
**21 CFR Part 876**
122. In § 876.5980, revise paragraph (b)(1) to read as follows:
§ 876.5980
(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**
**21 CFR Part 878**
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.
**21 CFR Part 878**
124. In § 878.4370, revise paragraph (b) to read as follows:
§ 878.4370
(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.
**21 CFR Part 878**
125. In § 878.4495, revise paragraph (b) to read as follows:
§ 878.4495
(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.
**21 CFR Part 878**
126. In § 878.4580, revise paragraph (b) to read as follows:
§ 878.4580
(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.
**21 CFR Part 878**
127. In § 878.5070, revise paragraph (b) to read as follows:
§ 878.5070
(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**
**21 CFR Part 880**
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.
**21 CFR Part 880**
129. In § 880.5580, revise paragraph (b) introductory text to read as follows:
§ 880.5580
(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:
**21 CFR Part 880**
130. In § 880.5680, revise paragraph (b) to read as follows:
§ 880.5680
(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.
**21 CFR Part 880**
131. In § 880.5780, revise paragraph (a)(2) to read as follows:
§ 880.5780
(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.
**21 CFR Part 880**
132. In § 880.6250, revise paragraph (b) to read as follows:
§ 880.6250
(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.
**21 CFR Part 880**
133. In § 880.6375, revise paragraph (b) to read as follows:
§ 880.6375
(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.
**21 CFR Part 880**
134. In § 880.6760, revise paragraph (b) to read as follows:
§ 880.6760
(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**
**21 CFR Part 882**
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.
**21 CFR Part 882**
136. In § 882.1020, revise paragraph (b) to read as follows:
§ 882.1020
(b) *Classification.* Class II (special 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.
**21 CFR Part 882**
137. In § 882.1030, revise paragraph (b) to read as follows:
§ 882.1030
(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.
**21 CFR Part 882**
138. In § 882.1470, revise paragraph (b) introductory text to read as follows:
§ 882.1470
(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:
**21 CFR Part 882**
139. In § 882.1540, revise paragraph (b) to read as follows:
§ 882.1540
(b) *Classification.* Class II (special 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.
**21 CFR Part 882**
140. In § 882.1560, revise paragraph (b) to read as follows:
§ 882.1560
(b) *Classification.* Class II (special 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.
**21 CFR Part 882**
141. In § 882.1855, revise paragraph (b) to read as follows:
§ 882.1855
(b) *Classification.* Class II (special 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.
**21 CFR Part 882**
142. In § 882.4060, revise paragraph (b) to read as follows:
§ 882.4060
(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.
**21 CFR Part 882**
143. In § 882.4545, revise paragraph (b) to read as follows:
§ 882.4545
(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.
**21 CFR Part 882**
144. In § 882.5895, revise paragraph (b) introductory text to read as follows:
§ 882.5895
(b) *Classification.* Class II (special 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**
**21 CFR Part 884**
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.
**21 CFR Part 884**
146. In § 884.1630, revise paragraph (b) to read as follows:
§ 884.1630
(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.
**21 CFR Part 884**
147. In § 884.2990, revise paragraph (b) to read as follows:
§ 884.2990
(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.
**21 CFR Part 884**
148. In § 884.3200, revise paragraph (b) to read as follows:
§ 884.3200
(b) *Classification.* Class II (special 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.
**21 CFR Part 884**
149. In § 884.4400, revise paragraph (b) to read as follows:
§ 884.4400
(b) *Classification.* Class II (special 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.
**21 CFR Part 884**
150. In § 884.4530, revise paragraph (b)(1) to read as follows:
§ 884.4530
(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.
**21 CFR Part 884**
151. In § 884.4900, revise paragraph (b) to read as follows:
§ 884.4900
(b) *Classification.* Class II (special 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.
**21 CFR Part 884**
152. In § 884.5200, revise paragraph (b) introductory text to read as follows:
§ 884.5200
(b) *Classification.* Class II (special 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:
**21 CFR Part 884**
153. In § 884.5390, revise paragraph (b) to read as follows:
§ 884.5390
(b) *Classification.* Class II (special 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.
**21 CFR Part 884**
154. In § 884.5400, revise paragraph (b) to read as follows:
§ 884.5400
(b) *Classification.* Class II (special 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.
**21 CFR Part 884**
155. In § 884.5425, revise paragraph (b)(2) to read as follows:
§ 884.5425
(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.
**21 CFR Part 884**
156. In § 884.5435, revise paragraph (b) to read as follows:
§ 884.5435
(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.
**21 CFR Part 884**
157. In § 884.6120, revise paragraph (b) to read as follows:
§ 884.6120
(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.
**21 CFR Part 884**
158. In § 884.6130, revise paragraph (b) to read as follows:
§ 884.6130
(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.
**21 CFR Part 884**
159. In § 884.6150, revise paragraph (b) to read as follows:
§ 884.6150
(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.
**21 CFR Part 884**
160. In § 884.6160, revise paragraph (b) to read as follows:
§ 884.6160
(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**
**21 CFR Part 886**
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.
**21 CFR Part 886**
162. In § 886.1120, revise paragraph (b) to read as follows:
§ 886.1120
(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.
**21 CFR Part 886**
163. In § 886.1250, revise paragraph (b) to read as follows:
§ 886.1250
(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.
**21 CFR Part 886**
164. In § 886.1570, revise paragraph (b) to read as follows:
§ 886.1570
(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.
**21 CFR Part 886**
165. In § 886.1780, revise paragraph (b)(1) to read as follows:
§ 886.1780
(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.
**21 CFR Part 886**
166. In § 886.1850, revise paragraph (b) to read as follows:
§ 886.1850
(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.
**21 CFR Part 886**
167. In § 886.1945, revise paragraph (b) to read as follows:
§ 886.1945
(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.
**21 CFR Part 886**
168. In § 886.3320, revise paragraph (b) to read as follows:
§ 886.3320
(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.
**21 CFR Part 886**
169. In § 886.4070, revise paragraph (b) to read as follows:
§ 886.4070
(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.
**21 CFR Part 886**
170. In § 886.4150, revise paragraph (b) to read as follows:
§ 886.4150
(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.
**21 CFR Part 886**
171. In § 886.4250, revise paragraph (b) to read as follows:
§ 886.4250
(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.
**21 CFR Part 886**
172. In § 886.4335, revise paragraph (b) to read as follows:
§ 886.4335
(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.
**21 CFR Part 886**
173. In § 886.4400, revise paragraph (b) to read as follows:
§ 886.4400
(b) *Classification.* Class II (special 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.
**21 CFR Part 886**
174. In § 886.4440, revise paragraph (b) to read as follows:
§ 886.4440
(b) *Classification.* Class II (special 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.
**21 CFR Part 886**
175. In § 886.4790, revise paragraph (b) to read as follows:
§ 886.4790
(b) *Classification.* Class II (special 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**
**21 CFR Part 888**
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.
**21 CFR Part 888**
177. In § 888.1240, revise paragraph (b) to read as follows:
§ 888.1240
(b) *Classification.* Class II (special 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.
**21 CFR Part 888**
178. In § 888.4580, revise paragraph (b) to read as follows:
§ 888.4580
(b) *Classification.* Class II (special 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**
**21 CFR Part 890**
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.
**21 CFR Part 890**
180. In § 890.1450, revise paragraph (b) to read as follows:
§ 890.1450
(b) *Classification.* Class II (special 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.
**21 CFR Part 890**
181. In § 890.5100, revise paragraph (b) to read as follows:
§ 890.5100
(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.
**21 CFR Part 890**
182. In § 890.5110, revise paragraph (b) to read as follows:
§ 890.5110
(b) *Classification.* Class II (special 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.
**21 CFR Part 890**
183. In § 890.5250, revise paragraph (b) to read as follows:
§ 890.5250
(b) *Classification.* Class II (special 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.
**21 CFR Part 890**
184. In § 890.5360, revise paragraph (b) to read as follows:
§ 890.5360
(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.
**21 CFR Part 890**
185. In § 890.5500, revise paragraph (b) to read as follows:
§ 890.5500
(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.
**21 CFR Part 890**
186. In § 890.5575, revise paragraph (b) to read as follows:
§ 890.5575
(b) *Classification.* Class II (special 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**
**21 CFR Part 892**
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.
**21 CFR Part 892**
188. In § 892.1000, revise paragraph (b) to read as follows:
§ 892.1000
(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.
**21 CFR Part 892**
189. In § 892.1560, revise paragraph (b) to read as follows:
§ 892.1560
(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.
**21 CFR Part 892**
190. In § 892.1610, revise paragraph (b) to read as follows:
§ 892.1610
(b) *Classification.* Class II (special 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.
**21 CFR Part 892**
191. In § 892.1650, revise paragraph (b) to read as follows:
§ 892.1650
(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.
**21 CFR Part 892**
192. In § 892.1670, revise paragraph (b) to read as follows:
§ 892.1670
(b) *Classification.* Class II (special 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.
**21 CFR Part 892**
193. In § 892.1680, revise paragraph (b) to read as follows:
§ 892.1680
(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.
**21 CFR Part 892**
194. In § 892.1730, revise paragraph (b) to read as follows:
§ 892.1730
(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.
**21 CFR Part 892**
195. In § 892.1820, revise paragraph (b) to read as follows:
§ 892.1820
(b) *Classification.* Class II (special 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.
**21 CFR Part 892**
196. In § 892.1850, revise paragraph (b) to read as follows:
§ 892.1850
(b) *Classification.* Class II (special 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.
**21 CFR Part 892**
197. In § 892.1860, revise paragraph (b) to read as follows:
§ 892.1860
(b) *Classification.* Class II (special 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.
**21 CFR Part 892**
198. In § 892.1870, revise paragraph (b) to read as follows:
§ 892.1870
(b) *Classification.* Class II (special 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.
**21 CFR Part 892**
199. In § 892.1900, revise paragraph (b) to read as follows:
§ 892.1900
(b) *Classification.* Class II (special 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.
**21 CFR Part 892**
200. In § 892.2030, revise paragraph (b) to read as follows:
§ 892.2030
(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.
**21 CFR Part 892**
201. In § 892.2040, revise paragraph (b) to read as follows:
§ 892.2040
(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.
**21 CFR Part 892**
202. In § 892.5730, revise paragraph (b) to read as follows:
§ 892.5730
(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.