A year into the current public health emergency, the FDA’s Center for Devices and Radiological Health (CDRH) announced on Thursday, April 15, 2021, that the center is “prioritizing and triaging our work using existing resources in order to focus on our COVID-19 response, resulting in delays in some other work areas.” Dr. Jeff Shuren, Director, CDRH, and Dr. William Maisel, Director, Office of Product Evaluation and Quality at CDRH, reported that the astounding numbers of pre-EUA and EUA submissions received for COVID-19 tests and collection kits created a significant workload that has strained the center’s resources in the review of in vitro diagnostic (IVD) files. Shuren and Maisel report that current pre-EUA and EUA submissions under active review across the center exceeds 600 with an average receipt of more than 40 new pre-EUA and EUA submissions per week in addition to non-COVID-related submissions. Every office in CDRH has been heavily impacted and staff and resources have been reallocated from product areas less impacted to those with increased submission volume. CDRH staff have been working nights and weekends, and Congress has approved one-time funding support to hire temporary employees and use third party reviewers.

Despite all these efforts, Shuren and Maisel expect delays in meeting review timelines for certain non-COVID-19 submissions, even for files tied to Medical Device User Fee Amendments (MDUFA) commitments. With the biggest challenges facing the IVD product space, CDRH will be declining IVD pre-submissions that are not related to COVID-19, companion diagnostics, a breakthrough designation request, or have a significant public health impact.  

Other CDRH divisions reviewing files for PPE (e.g., respirators, facemasks, gowns, gloves), ventilators, and general hospital equipment have also experienced significant increases in workload; however, it is expected that they will continue to be able to meet MDUFA timelines for most marketing submissions. These divisions are experiencing longer review timelines for pre-submissions, and it is anticipated that pre-submissions in these divisions will be completed within 120 days, rather than the usual 70 days. Finally, premarket submission reviews and pre-submissions in other product areas are generally continuing under typical timelines with a small number of submissions experiencing delays on a case-by-case basis.

If you have questions or concerns about how these changes may impact your FDA-regulated medical product, please email Dr. Heather Hatcher, Regulatory Scientist with our WBD Regulatory Affairs Advance team at heather.hatcher@wbd-us.com