Ann: Quarterly Activities/Appendix 4C Cash Flow Report, page-30

FDA 'working around the clock' with COVID-19 workload, all reviews impacted: CDRH chief
Published May 20, 2021

Greg SlabodkinSenior Editor


Danielle Ternes
Dive Brief:

• FDA continues to struggle in 2021 in balancing its coronavirus-related regulatory workload and non-COVID-19 activities, with the agency's performance in conducting 510(k) reviews suffering, according to Jeff Shuren, director of the Center for Devices and Radiological Health.

• Review times for emergency use authorizations and pre-EUAs have increased which has "adversely impacted" reviews of non-COVID submissions including premarket approval applications, Shuren told the Food & Drug Law Institute annual conference Wednesday. Despite efforts to mitigate its coronavirus workload challenges, the CDRH chief said it's possible this year that FDA might miss some of the Medical Device User Fee Amendments performance goals to reduce the average total time to decision for PMA applications and 510(k) submissions.

• FDA won't review pre-submissions for in vitro diagnostic products until 2022 due to these constraints, Shuren said, unless they are for COVID-19-related, breakthrough designations or companion diagnostics. But "all of the [IVD] premarket submissions on hold will move forward, they'll have a lead reviewer, we will make progress" in 2021. Shuren acknowledged that the agency "might not meet" its MDUFA deadlines in those areas.