On August 18, 2017, in the nick of time, President Trump signed the FDA User Fee Reauthorization Bill of 2017 (FDARA) (H.R. 2430) into law, bringing a sigh of relief from both FDA and Industry. The law reauthorizes the Prescription Drug User Fee Act (PDUFA) for the fifth time, the Medical Device User Fee Amendments (MDUFA) for the third time, and both the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA) for the first time. FDARA reauthorizes the user fee legislations through FY 2022. Without reauthorization, FDA’s ability to collect user fees would have expired on September 30, 2017, and over 5,000 FDA employees would have lost their jobs, severely impacting Agency operations.

FDA and Industry are both praising the bipartisan effort. James C. Greenwood, President and CEO of the Biotechnology Innovation Organization (BIO), called the legislation a “historic achievement.” In a recent “tweet,” Scott Gottlieb, FDA Commissioner, thanked the House for passing FDARA, saying it is “key for FDA, patients. ”FDARA’s impact on the medical device industry extends beyond just reauthorizing MDUFA. It specifically (1) directs FDA to implement new inspection policies, which also provide greater flexibility for obtaining Certificates for Foreign Governments (CFGs), (2) incentivizes the development of pediatric devices, (3) creates a more flexible path to market for certain new medical device accessories, (4) establishes a category of over-the-counter hearing aids, (5) fosters innovation in medical imaging devices that use contrast agents, and (6) requires FDA to establish voluntary postmarket surveillance pilot projects. This client alert summarizes these key provisions and others that will impact the medical device industry.