refers to an establishment that is located in a foreign country and is the site where a blood product that is imported or offered for import into the United States was manufactured.
607.80Applicability 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.
United States Government work; public domain under 17 U.S.C. § 105.