This post was written by Erin Janssen.
Draft guidance released by FDA on December 27, 2011, “Center for Devices and Radiological Health (CDRH) Appeals Processes,” describes the processes available to outside stakeholders to request additional review of decisions and actions by CDRH employees, provides general information about each process, and offers guidance on how to submit related requests to CDRH and FDA. FDA requests comments on the document by April 26, 2012.