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Zdrowie i gospodarka · 25.04.2000

Medical Devices; Device Tracking

The Food and Drug Administration (FDA) is proposing to amend the medical device tracking regulations. The scope of the regulation and certain patient confidentiality requirements must be amended to conform to changes made in section 519(e) of the Federal Food, Drug, and Cosmetic Act (the act) by the FDA Modernization Act of 1997 (FDAMA). FDA also proposes nonsubstantive revisions to remove outdated references or simplify terminology.

Source: Federal Register — Food and Drug AdministrationOpen original release →