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.
21 CFR Part 607 · Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices
§ 607.80 Applicability of part 607 to licensed devices
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
FDA guidance that cites § 607.80
- Review and Update of Device Establishment Inspection Processes and Standards: Guidance for Industry 29 Jun 2020
Amendment history
Federal Register documents that created or amended this section.
- 38 FR 32056 20 Nov 1973
- 81 FR 60223 31 Aug 2016