Center for Devices and Radiological Health Appeals Processes; Guidance for Industry and FDA Staff; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the 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 or actions by CDRH employees which include requests for supervisory review of an action, petitions, and hearings. Of these, the most commonly used process is the request for supervisory review (a "10.75 appeal"). This document provides general information about each process as well as guidance on how to submit related requests to CDRH and FDA.