Federal Register Notice: FDA is making available a guidance entitled Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A. It provides the Center’s interpretation of key provisions of FDCA section 517A on requests for documentation of rationales for significant decisions and requests for supervisory review of regulatory decisions and actions taken by CDRH. To download this guidance, click here. To view this notice, click here.