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Geschäft · 2.1.20131 Min. Lesezeit
Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s; Availability
Lokale automatische Übersetzung · Originalsprache der Quelle
Zusammenfassung
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Refuse to Accept Policy for 510(k)s." The purpose of this document is to explain the procedures and criteria FDA intends to use in determining whether a 510(k) submission is administratively complete, which determines whether it should be accepted for substantive review and clearance. This guidance is applicable to 510(k)s reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →