21 CFR 607.80
§ 607.80 Applicability of part 607 to licensed devices.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 607.80, § 607.80 Applicability of part 607 to licensed devices, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88408
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Full text
Manufacturers of products that meet the definition of a device under the Federal Food, Drug, and Cosmetic Act and that are licensed under section 351 of the Public Health Service Act, as well as licensed biological products used in the manufacture of a licensed device, must register and list following the procedures under this part, with respect to their manufacture of those products, unless otherwise noted in this section.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.