title: Medical devices; humanitarian use of devices--FDA. Direct final rule; withdrawal.
abstract: The Food and Drug Administration (FDA) published, in the Federal Register of April 17, 1998 (63 FR 19185), a direct final rule to implement the amendments to the humanitarian use devices provision of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The comment period closed July 1, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D004638:Emergency Treatment / Q000592:standards; D004869:Equipment Safety; D006801:Humans; D012107:Research Design / Q000592:standards*; D012309:Risk-Taking; D014481:United States; D014486:United States Food and Drug Administration