SEN. KASSEBAUM'S DRAFT FDA REFORM MEASURE STRENGTHENS REVIEW DEADLINE ENFORCEMENT; FDA RETAINS FINAL SIGN-OFF ON MOST THIRD-PARTY DEVICE REVIEWS
This article was originally published in The Gray Sheet
Executive Summary
Draft FDA reform legislation released by the Senate Labor and Human Resources Committee on Nov. 3 would allow devices approved for marketing in the European Union or the United Kingdom to be marketed in the U.S. without FDA approval if the agency fails to meet review deadlines outlined in the "discussion draft."