title: Medical devices; humanitarian use of devices--FDA. Final rule.
abstract: The Food and Drug Administration (FDA) is issuing a final rule amending the regulations governing humanitarian use devices (HUD's). These amendments are being made to implement provisions of the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA).
mesh_terms: D000533:Altruism; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004864:Equipment and Supplies; D014481:United States; D014486:United States Food and Drug Administration