21 CFR 822.1
§ 822.1 What does this part cover?
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 822.1, § 822.1 What does this part cover?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88920
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Full text
This part implements section 522 of the Federal Food, Drug, and Cosmetic Act by providing procedures and requirements for postmarket surveillance of class II and class III devices that meet any of the following criteria:
(a) Failure of the device would be reasonably likely to have serious adverse health consequences;
(b) The device is intended to be implanted in the human body for more than 1 year;
(c) The device is intended to be used outside a user facility to support or sustain life. If you fail to comply with requirements that we order under section 522 of the Federal Food, Drug, and Cosmetic Act and this part, your device is considered misbranded under section 502(t)(3) of the Federal Food, Drug, and Cosmetic Act and you are in violation of section 301(q)(1)(C) of the Federal Food, Drug, and Cosmetic Act; or
(d) The device is expected to have significant use in pediatric populations.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.