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FDA Now Accepting Non-COVID Pre-Submissions for IVD Tests

June 3, 2022 | For many medical device companies, an announcement earlier this week by the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) surely provoked a sigh of relief. As of June 1, 2022, CDRH says, it will be accepting all non-COVID in vitro diagnostic (IVD) pre-submissions. Last year, faced with an unprecedented number of Emergency Use Authorization (EUA) requests and pre-EUA submissions for COVID-19 tests and collection kits, CDRH stopped reviewing some non-COVID IVD pre-submissions (the exceptions included breakthrough designation requests, companion diagnostics, and study risk determinations).

CDRH’s IVD office has increased staffing to address the heightened volume of work and permit it to devote more resources to conventional premarket reviews, indicates William Maisel, M.D., director of CDRH’s Office of Product Evaluation and Quality, in an FDA website post. But since the COVID-related workload remains high, he adds, it is likely that review of the IVD pre-submissions that have been in limbo will require an extended timeline.

Also under consideration is withdrawal of guidance allowing sponsors adversely impacted by the pandemic more time to address submission deficiencies, says Maisel, noting a previously announced return to pre-pandemic review times for most submissions and resumed acceptance of pre-submissions requesting feedback for IVDs that require or would be likely to require a Premarket Approval or De Novo submission.

In the same post, Director Jeff Shuren, M.D., J.D., reports that CDRH continues to manage a high volume of both conventional premarket submissions and EUAs. Over 8,000 EUA requests and pre-EUA requests for devices have been requested since January 2020, and CDRH continues to receive nearly 120 such requests on monthly basis—the majority for IVD tests.

Shuren says that to date CDRH has granted EUAs or traditional marketing authorizations to over 2,300 medical devices for COVID-19 (nearly 600 in fiscal year 2022 alone). That amounts to 15 times more EUAs for this public health emergency than all other previous emergencies combined.

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