FDA Reviews Likely to Slow During Pandemic

FDA Commissioner Stephen Hahn said the Center for Devices and Radiological Health (CDRH) continues to meet its Medical Device User Fee Amendments (MDUFA) review goals during the pandemic — but that may soon change.

With many staff working on COVID-19 activities, “it is possible that we will not be able to sustain our current level of performance indefinitely,” Hahn said.

CDRH has already extended applicant response dates by 90 days for many applications, including 510(k) premarket notifications. The extension is likely to impact the agency’s ability to meet MDUFA commitments for “total time to decision,” Hahn said.