§ 607.80. Applicability of part 607 to licensed devices.
75 words·~1 min read·
/us/cfr/t21/s§ 607.80·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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]