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Pubmed for Handhelds

PUBMED FOR HANDHELDS

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  • Title: Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, distributor reporting. Food and Drug Administration, HHS. Final rule.
    Journal: Fed Regist; 2000 Jan 26; 65(17):4112-21. PubMed ID: 11010653.
    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).
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