FDA proposes rule to codify existing guidance on supervisory review of CDRH decisions

On January 17, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed rule to update the framework for requesting internal agency supervisory review of certain decisions related to devices regulated by the Center for Devices and Radiological Health (CDRH). If finalized, this proposed rule will reflect the recommendations in a September 2017 FDA guidance document and will follow the procedures and timeframes under the Federal Food, Drug and Cosmetic Act (FDC Act). Of note, the proposed rule defines “significant decisions” and provides new procedural requirements and timelines for requesting supervisory review within CDRH of decisions made by CDRH that are not considered “significant decisions.”