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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2020.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2020]
[CITE: 21CFR860.15]
See Related Information on Exemptions from sections 510, 519, and 520(f) of the Federal Food, Drug, and Cosmetic Act. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

PART 860 -- MEDICAL DEVICE CLASSIFICATION PROCEDURES

Subpart A - General

Sec. 860.15 Exemptions from sections 510, 519, and 520(f) of the Federal Food, Drug, and Cosmetic Act.

(a) A panel recommendation to the Commissioner that a device be classified or reclassified into class I will include a recommendation as to whether the device should be exempted from some or all of the requirements of one or more of the following sections of the Federal Food, Drug, and Cosmetic Act: Section 510 (registration, product listing, and premarket notification), section 519 (records and reports) and section 520(f) (good manufacturing practice requirements of the quality system regulation), and, in the case of a recommendation for classification into class II, whether the device should be exempted from the premarket notification requirement under section 510.

(b) A regulation or an order classifying or reclassifying a device into class I will specify which requirements, if any, of sections 510, 519, and 520(f) of the Federal Food, Drug, and Cosmetic Act the device is to be exempted from or, in the case of a regulation or an order classifying or reclassifying a device into class II, whether the device is to be exempted from the premarket notification requirement under section 510, together with the reasons for such exemption.

(c) The Commissioner will grant exemptions under this section only if the Commissioner determines that the requirements from which the device is exempted are not necessary to provide reasonable assurance of the safety and effectiveness of the device.

[83 FR 64455, Dec. 17, 2018]

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