Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices." This document describes FDA's intent with regard to enforcement of premarket notification (510(k)) requirements for certain in vitro diagnostic and radiology devices under the regulations.