USA – Impact of COVID-19 emergency on US FDA interactions with medical device manufacturers

The US Food and Drug Administration may revise performance goals and timelines set under the Medical Device User Fee Amendments IV (MDUFA IV) as emergency efforts targeting the coronavirus pandemic take up more of the agency’s time.

New guidance from FDA explains the regulator’s approach to conducting premarket medical device reviews, adjusting user fees and consulting with manufacturers during the COVID-19 crisis. Given FDA’s ongoing work on Emergency Use Authorizations (EUAs) for ventilators, IVD test kits and other medical equipment in high demand, the guidance states that some performance goals and user fee commitments established under MDUFA IV may be missed or delayed. Furthermore, US medical device market registrants should expect greater use of video- and teleconferencing when meeting with FDA officials for 510(k) premarket notifications, Premarket Approvals (PMA) or Q-Submission consultations…