Earlier this year, CDRH gave a resource update and set expectations for product submission reviews, as the agency has experienced a record number of authorizations as a result of the pandemic. The significantly longer-than-normal review timelines was a result of high submission volume and the fact that more than half of CDRH staff and managers were part of the center’s COVID-19 response.
As the year comes to a close, CDRH Director Jeff Shuren, M.D. and Director of the Office of Product Evaluation and Quality William Maisel offered another update on the timeline for submission reviews—while also noting that they expect to see a transition towards more normal operations in 2022. “For the second consecutive year, CDRH experienced an increase in the number of “conventional” premarket submissions (510(k)s, De Novos, Premarket Approvals (PMAs) and Q-Submissions (Q-Subs)), receiving close to 18,000 submissions in Fiscal Year (FY) 2021,” Shuren and Maisel stated. “In addition, while the number of pre-EUA and EUA submissions declined from FY20 to FY21, we still received more than 2,200 in FY21. This two-year ‘sprint’ (more aptly described as an ultra-marathon) has facilitated the availability of COVID-19 tests and collection kits, personal protective equipment (PPE), ventilators, and other devices to prevent, diagnose and treat COVID-19 related symptoms. However, the sustained high volume continues to strain center resources.” Thus far CDRH has issued more than 1900 medical devices for COVID-19 indications, including 15-times more EUAs than during all other previous public health emergencies combined.
Regarding IVD products, the center expects to receive more than 1000 IVD pre-EUA and EUA submissions next year. Last June the agency resumed non-COVID IVD marketing submissions and extended submission timelines.
“While CDRH’s response to the pandemic remains a top priority, we anticipate a gradual transition back toward normal review timelines in 2022. Our ability to reach and sustain “normal” review times will depend on the course of the pandemic and adequate resources, and we appreciate your patience and understanding while we continue to respond to the public health emergency. CDRH will continue to keep stakeholders apprised of these phased transitions through periodic updates,” Shuren and Maisel concluded.