The Food and Drug Administration (FDA) issued guidance to answer frequently asked questions (FAQs) on the impact of the COVID-19 public health emergency (PHE) on formal meetings and user fee applications for medical devices. The guidance is intended to provide answers to FAQs about regulatory and policy issued related to device development during the COVID-19 PHE.
Additional highlights from the guidance follow:
- Meetings with Industry – The FDA intends to hold all previously scheduled meetings with industry virtually, rather than in-person, as well as all Center for Devices and Radiological Health (CDRH) meetings. Additionally, the agency is continuing to accept new Q-submissions requests and Q-submissions requests for CDRH meetings are currently being scheduled as teleconference meetings.
- Medical Device User Fee Amendments (MDUFA) Goals and Timelines – The FDA emphasizes that it remains committed to meeting the MDUFA performance goals. However, the agency notes that due to shifts in workforce to accommodate COVID-19 Emergency Use Authorization activities, it may be possible that the FDA will not be able to sustain current performance levels indefinitely. The agency details that should an Original premarket approval application (PMA), panel track PMA supplement, premarket [510(k)] submission, or De Novo request miss its MDUFA performance goal, the FDA will follow the missed MDUFA decision procedures found in this guidance.