Jul 1, 2020
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.
FDA’s Center for Devices and Radiological Health (CDRH) now hosts teleconferences rather than in-person meetings with medical device and IVD companies; all requests from industry for in-person meetings will be processed as requests for teleconference meetings, according to the guidance.
Applicants may continue to request Q-submission consultations with FDA, to be conducted via teleconference or written responses from the agency.
Regarding advisory committee meetings, FDA plans virtual meetings, as well.
As FDA’s work on EUAs and related efforts to fight COVID-19, agency resources have had to be reallocated and reassigned, which may mean that “it is possible that we will not be able to sustain our current performance levels indefinitely,” the guidance states.
Based on the new FDA guidance, US market applicants whose devices do not target COVID-19 may face delayed premarket review timeframes as the agency allocates internal resources to EUA designations and other pandemic-related activities.
Adverse event reporting for FDA EUA-designated medical devices and IVDs
US FDA's Emergency Use Authorization (EUA) pathway allows rapid market entry for medical devices in short supply
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