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e-CFR data is current as of February 25, 2021 |
Title 21 → Chapter I → Subchapter F → Part 607 → Subpart E |
Title 21: Food and Drugs
PART 607—ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS AND LICENSED DEVICES
Subpart E—Establishment Registration and Product Listing Of Licensed Devices
Contents
§607.80 Applicability of part 607 to licensed devices.
Back to Top§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]