Last month, President Trump signed the FDA Reauthorization Act of 2017 (FDARA). FDARA reauthorizes the Medical Device User Fee Amendments (MDUFA), allowing FDA to collect medical device user fees for fiscal years 2018 to 2022 after FDA’s current user fee authority ends on September 30, 2017. Notably, the reauthorized MDUFA adds a substantial new user fee for de novo classification requests. FDARA also contains important substantive amendments to the FDCA, including provisions modifying FDA’s approach and procedures for device establishment inspections, clarifying the premarket review process for medical imaging devices intended to be used with an approved contrast agent, addressing the classification of accessory devices, and requiring FDA to report on servicing of devices.
A full summary of the device-related provisions of FDARA is available in our recent Covington alert.