Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A; Guidance for Industry and Food and Drug Administration Staff

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: Questions and Answers About 517A." This document provides CDRH's interpretation of key provisions of section 517A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which were added by the FDA Safety and Innovation Act (FDASIA), as these provisions pertain to requests for documentation of rationales for significant decisions and requests for supervisory review of regulatory decisions and actions taken by CDRH.