Medical devices; 30-day notices and 135-day PMA supplement review--FDA. Direct final rule; withdrawal.
The Food and Drug Administration (FDA) published, in the Federal Register of April 27, 1998 (63 FR 20530), a direct final rule to implement the amendments to the premarket approval provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The comment period closed on July 13, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.
D018795:Device Approval / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety; D004864:Equipment and Supplies; D005568:Forms and Records Control / Q000331:legislation & jurisprudence; D007221:Industry / Q000331:legislation & jurisprudence*; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration