(a) This part establishes establishment registration and product listing requirements for manufacturers of human blood and blood products.(b) This part establishes establishment registration and product listing requirements for 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.81 FR 60221, Aug. 31, 2016