FDA Proposes Medical Device Review Regulation
FDA will publish in the 1/17 Federal Register a notice proposing to implement regulations on internal agency supervisory review of certain decisions related to medical devices regulated by CDRH to conform to applicable provisions of the FDA Safety and Innovation Act and the 21st Century Cures Act. The notice says the agency is taking the action to codify the procedures and timeframes for supervisory review of significant decisions pertaining to devices within CDRH. It says FDA also is proposing regulations to provide new procedural requirements for requesting internal agency supervisory review within CDRH of other types of decisions made by the Center not addressed in the two laws. The action is part of FDA’s implementation of two executive orders requiring a comprehensive review of regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction, FDA says.