Food and Drug Administration. ... parts, accessories, or articles) is intended to be further processed by, or incorporated into a drug, biological product, device, food, food additive, color ... premarket reports (a new category of premarket application for reprocessed single-use devices), BLAs, certain supplements, and 510(k)s.
|Title||:||Regulatory procedures manual|
|Author||:||United States. Food and Drug Administration. Office of Enforcement|