21 CFR 806.1

§ 806.1 Scope.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 806.1, § 806.1 Scope, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88730
Permanent ID: ys:prov:88730@1
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Full text

(a) This part implements the provisions of section 519(g) of the Federal Food, Drug, and Cosmetic Act (the act) requiring device manufacturers and importers to report promptly to the Food and Drug Administration (FDA) certain actions concerning device corrections and removals, and to maintain records of all corrections and removals regardless of whether such corrections and removals are required to be reported to FDA. (b) The following actions are exempt from the reporting requirements of this part: (1) Actions taken by device manufacturers or importers to improve the performance or quality of a device but that do not reduce a risk to health posed by the device or remedy a violation of the act caused by the device. (2) Market withdrawal as defined in § 806.2(i) (3) Routine servicing as defined in § 806.2(l). (4) Stock recovery as defined in § 806.2(m).

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.