The FDA may not be able to meet its deadlines for reviewing medical device applications due to constraints posed by the coronavirus pandemic, Commissioner Stephen Hahn announced yesterday.
The Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) are still on track to meet the goals set in user-fee agreements, but that doesn’t mean they will necessarily continue to be able do so, according to Hahn.
“We continue to perform our user fee review activities and our application review teams across the agency remain focused on their work as we do everything possible to maintain continuity of operations in a very dynamic situation,” he said in a news release. “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.”
The agency is holding to the 90-day extension it announced April 4 for responding to marketing notifications that were placed on hold in March. The extension applies to applications for premarket notifications (510(k)s), original and supplemental applications for premarket approval (PMA) and humanitarian device exemptions (HDE), and De Novo classification requests. Earlier this week the FDA announced it was indefinitely postponing the May 5, 2020 meeting it had set to discuss the Medical Device User Fee Amendments (MDUFA) for fiscal years 2023 through 2027.
Device sponsors whose applications are already on hold need not take any action at this time, as CDRH will extend them automatically, the agency said. Companies and organizations that have post-approval or 522 study reports, IDE annual reports and PMA reports should submit those reports whenever possible, the agency added.
“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. “Additionally, with many staff in CDRH working on COVID-19 activities related to pre-Emergency Use Authorizations (pre-EUAs), EUAs, and Immediately In Effect (IIE) guidance documents, it is possible that we will not be able to sustain our current level of performance indefinitely. However, this will be assessed on an ongoing basis.”
