Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological Health Appeals Processes; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Center for Devices and Radiological Health (CDRH) Appeals Processes." This document describes the processes available to outside stakeholders to request additional review of decisions and actions by CDRH employees. The document also provides general information about each process as well as guidance on how to submit related requests to CDRH and FDA. This draft guidance is not final nor is it in effect at this time.