21 CFR § 607.80 - Applicability of part 607 to licensed devices.

---
identifier: "/us/cfr/t21/s607.80"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 607.80 - Applicability of part 607 to licensed devices."
title_number: 21
title_name: "Food and Drugs"
section_number: "607.80"
section_name: "Applicability of part 607 to licensed devices."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "F"
subchapter_name: "BIOLOGICS"
part_number: "607"
part_name: "ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS AND LICENSED DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 351, 352, 355, 360, 371, 374, 381, 393; 42 U.S.C. 262, 264, 271."
regulatory_source: "40 FR 52788, Nov. 12, 1975, unless otherwise noted."
cfr_part: "607"
---


# 607.80 Applicability of part 607 to licensed devices.

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.

[81 FR 60223, Aug. 31, 2016]