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Imprese · 08/11/20161 min di lettura
Medical Device Reporting for Manufacturers; Guidance for Industry and Food and Drug Administration Staff; Availability
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Riepilogo
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Medical Device Reporting for Manufacturers; Guidance for Industry and Food and Drug Administration Staff." This guidance document is intended to assist medical device manufacturers meet applicable reporting and recordkeeping requirements for certain device-related adverse events and malfunctions.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →