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Pubmed for Handhelds

PUBMED FOR HANDHELDS

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  • Title: Medical devices; establishment registration and device listing for manufacturers and distributors of devices--FDA. Direct final rule.
    Journal: Fed Regist; 1998 Sep 29; 63(188):51825-7. PubMed ID: 10185812.
    Abstract:
    The Food and Drug Administration (FDA) is amending certain regulations governing establishment registration and device listing by domestic distributors. These amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comment and withdraws the direct final rule.
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