Pre-Submission Program Update from CDRH: A Bit of Welcome News

June 8, 2022By Allyson B. Mullen & Jeffrey N. Gibbs

CDRH appears to be taking another step towards returning to pre-pandemic life.  On May 31, Drs. Shuren and Maisel announced that OHT7 (formerly OIR) will now be accepting all types of pre-submissions (see announcement here).  As you’ll recall from our earlier post (here), OHT7 had only been accepting a limited number of non-COVID related pre-submissions since late last year and prior to that was only accepting pre‑submissions for COVID-related tests.

This update will likely come as a relief to many in the in vitro diagnostic space that have been wanting to seek feedback on their non-COVID related tests in anticipation of a premarket submission.  The announcement notes the sizable number of COVID and non-COVID related submissions – over 1,000 COVID EUAs and pre-EUAs for devices alone since the start of the year – that CDRH has been handling during the pandemic.

An unanswered question from the Center’s update, however, is how quickly these newly accepted pre-submissions will be reviewed.  In the Center’s December update, it noted that pre-submission review times were extended to 120 days, as compared to the usual 70-day time frame, in many of the busiest Offices, including OHT7.  While the announcement touts additions of personnel and funding to support this move, we expect industry may need to be patient while OHT7 adjusts to the inevitable influx of pre‑submissions headed its way.

Given the pent-up demand for pre-sub reviews and the continuing stream of COVID EUAs, companies should not expect that OHT7 will quickly return to the pre‑sub timeframes that pre-dated COVID.  This is particularly true because the pandemic is not over (despite everyone being over it!).  In fact, it is widely expected that HHS will extend the Public Health Emergency when it comes up for renewal in July.  With this most recent COVID wave, many industries are seeing an uptick in personnel being out sick, and OHT7 is presumably not exempt from this trend.  While it is welcome news that pre-subs will be accepted, companies should not be surprised if it takes weeks – or even months – longer to get OHT7’s feedback.

Categories: Medical Devices