title: Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, distributor reporting. Food and Drug Administration, HHS. Final rule.
abstract: The Food and Drug Administration (FDA) is amending its regulations governing reporting by manufacturers, importers, distributors and health care (user) facilities of adverse events related to medical devices. Amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA).
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety; D006801:Humans; D007255:Information Services / Q000331:legislation & jurisprudence; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration