FDA Issues Final Rule on Internal Agency Review of Device Decisions

Summary

The Food and Drug Administration (FDA) is issuing a final rule to amend its regulations regarding internal agency supervisory review of certain decisions related to devices regulated by the Center for Devices and Radiological Health (CDRH), in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA) and the 21st Century Cures Act (Cures Act). This action is part of FDA's efforts to implement Executive Orders (EOs) 13771 and 13777, which aim to reduce regulatory burdens while ensuring public health.