FDA device review times could get iffy, agency chief says

Dive Brief:

FDA Commissioner Stephen Hahn said Thursday that constraints on the agency as it responds to the COVID-19 outbreak could result in its device center not meeting premarket review timelines set forth in user fee agreements.
The Center for Devices and Radiological Health continues to meet its review goals, FDA reported. But the agency noted certain operational measures taken in response to the coronavirus, including the decision this month to extend response due dates by 90 days for marketing applications on hold, could be a factor that impacts that track record. "It is likely this extension of time will have an impact on the FDA and industry’s ability to meet the shared outcome goals for total time to decision as listed in the MDUFA IV commitment letter," Hahn said in a statement.
The update came shortly after the agency delayed indefinitely the first public meeting regarding the Medical Device User Fee Amendments for fiscal years 2023 through 2027, or MDUFA V. The meeting was originally set for April 7 and then rescheduled as a webcast for May 5, but the agency said Thursday it's "postponed until further notice."

Dive Insight:

Many staff in FDA's device center have been pulled into COVID-19 activities, including working on pre-Emergency Use Authorizations, EUAs, and Immediately In Effect guidance documents, according to the update from the agency Thursday.

That's no surprise; in the last month and a half, the agency has issued dozens of EUAs for diagnostic tests and devices to purify blood, decontaminate respirators, help wean patients off of ventilators, and more. To date, FDA has rolled out 13 guidances regarding medical devices used to help respond to the crisis, from remote monitoring devices and ventilators, to, more recently, infusion pumps and digital health devices for psychiatric disorders.

That reallocation of resources means "it is possible that we will not be able to sustain our current level of performance indefinitely," Hahn said, and the issue "will be assessed on an ongoing basis."

Still, device reviewers have thus far avoided a bottleneck, continuing to complete user fee work. FDA said it's doing "everything possible to maintain continuity of operations in a very dynamic situation." The agency had a similar message on drugs and biologics, saying it's currently meeting user fee goals but that an increase in shortages or supply disruptions may require the agency to reprioritize.

"Part of these actions include looking at ways to use technology and established agreements with our foreign counterparts to minimize impact to applications under review," FDA said.

Other factors that could slow companies' submission and review timelines, not mentioned in FDA's update, are disruptions to clinical studies and inspections, and the fact that much of FDA's staff transitioned to remote work.