FDA Reauthorization Act of 2017: Key Provisions Related to Medical Devices

FDA Reauthorization Act of 2017: Key Provisions Related to Medical Devices

September 20, 2017, Covington Alert

On August 18, 2017, President Trump signed H.R. 2430, the FDA Reauthorization Act of 2017, which became Public Law No. 115-52 (“FDARA”). Principally, FDARA reauthorizes the Food and Drug Administration (“FDA” or “the agency”) user fee programs, including the Medical Device User Fee Amendments, the Prescription Drug User Fee Amendments, the Biosimilars User Fee Amendments, and the Generic Drug User Fee Amendments. The agency’s existing authority to collect user fees under these programs ends on September 30, 2017. Under FDARA, the user fee programs have been reauthorized through fiscal year 2022. FDARA also includes important substantive amendments to the Federal Food, Drug, and Cosmetic Act (“FDCA”).