Dive Brief:

• FDA expects review timelines for non-COVID-19 in vitro diagnostics to remain extended in 2022 as it continues to struggle with an elevated workload due to the pandemic.
• The agency's Center for Devices and Radiological Health will start accepting pre-submissions requesting feedback for IVDs that require a PMA or De Novo filing next month, ending a multi-month hiatus, and hopes to start accepting all IVD pre-submission requests by the late spring or early summer. 
• However, the reviews may take longer than usual, with FDA aiming to "transition toward normal MDUFA timelines during the course of 2022." FDA is more upbeat on non-IVD medical devices, which it expects to "transition back to most of the MDUFA review timeframes" in 2022.

Dive Insight:

Jeff Shuren, director of FDA's CDRH, has made a series of statements about the impact of COVID-19 on the workload of his staff throughout the pandemic. The timelines set out by Shuren have shifted as the coronavirus pandemic has dragged on, with his July forecast that CDRH would largely be back to normal, with some remaining work and backlogs lingering, by 2022 now looking unlikely to come to pass.

Shuren set out the current situation in a post co-authored with William Maisel, director of the Office of Product Evaluation and Quality at CDRH. The pair provided an overview of 2021 before digging into the details of how they expect the coming year to play out.

CDRH expects its IVD review teams to bear the heaviest burdens in 2022. With FDA still receiving more than 100 IVD pre-EUA and EUA submissions for IVDs a month, it expects to process more than 1,000 of the filings next year. That forecast could prove highly conservative if COVID-19 variants necessitate the development of new tests.

The situation is normalizing, though. In June, CDRH resumed the review of the non-COVID IVD marketing submissions it paused in response to the crisis. The next step is to resume acceptance of requests for pre-submission feedback on PMA and De Novo filings, which is slated for Jan. 1, and then to reopen the doors to all IVD pre-submission requests by the late spring or early summer.

"Although it’s likely these IVD pre-submissions will initially be reviewed under an extended timeline, we expect to transition toward normal MDUFA timelines during the course of 2022," Shuren and Maisel said. 

The situation facing teams working on non-IVD devices is a little different. Changes such as a six-fold rise in submissions for personal protective equipment, compared to pre-pandemic volume, have led FDA to reassign staff, rely on overtime and take on contractors. Even so, pre-submission reviews have taken around seven weeks longer than before the pandemic and MDUFA timelines have been affected. 

While the situation has been disruptive for FDA and industry, it appears likely to be resolved faster than the stretched IVD timelines, with Shuren and Maisel predicting non-IVD review divisions will "transition back to most of the MDUFA review timeframes" during 2022 while warning that "some submissions may experience delays on a case-by-case basis."

FDA is trying to bring down review timelines while addressing other problems created by the pandemic, such as the emergence of a backlog of thousands of inspections it needs to complete across all its units.

As COVID-19 cases are surging from both the delta and omicron variants, Shuren and Maisel said in the plan that CDRH's "ability to reach and sustain 'normal' review times will depend on the course of the pandemic and adequate resources."