In a recent post on the FDA Voices blog, CDRH Director Jeff Shuren, M.D. and Director of the Office of Product Evaluation and Quality William Maisel took a look back at the achievements of CDRH over the past year. Faced with incredible challenges during the pandemic, the center authorized a record number of devices in 2020 and issued 10 times the amount of EUAs than all previous public health emergencies combined. CDRH also received more than 17,000 premarket submissions and more than 5500 pre-EUA and EUA submissions, which was an overall 38% increase. Thus far the agency has issued nearly EUAs or marketing authorization to nearly 1300 medical devices for COVID-19. In addition there are currently about 600 pre-EUA and EUA submissions under active review.
The increased workload has led the agency to prioritize responsibilities and reallocate staff and resources to product areas that have a higher submission volume and the greatest impact on public health. More than half of CDRH staff and managers have been a direct part of the center’s COVID-19 response.
“Not surprisingly, this unprecedented workload began to significantly strain center resources as we continued to prioritize COVID-19 work, particularly in the review of in vitro diagnostic (IVD) files. This is the office within CDRH that has been impacted the most from the beginning of the pandemic due to the astounding number of pre-EUA and EUA submissions received for COVID-19 tests and collection kits,” stated Shuren and Maisel. “Unless IVD pre-submissions are related to COVID-19, companion diagnostics, a breakthrough designation request, or have a significant public health impact, we have been unable to review them.” The center will also be declining IVD pre-submission requests that do not fall into the previously mentioned areas for the remainder of 2021 and expects to eliminate review initiation delays on non-COVID-19 IVD files within the next eight weeks.
The center is also experiencing longer review timelines for pre-submissions outside of IVD product areas and is expecting a review timeline of 120 days instead of 70 days.