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FDA Resumes Pre-Submission Requests for Non-COVID-19 IVD Tests

by | Jun 13, 2022 | Articles, News, Open Content

Effective June 1, the agency is once more accepting pre-submission requests for all in vitro diagnostics, including non-COVID-19 tests.

In a policy reversal, the FDA’s Center for Devices and Radiological Health (CDRH) announced that the agency would once more accept pre-submission requests for in all in vitro diagnostics, including non-COVID-19 tests, effective June 1, 2022. The move comes not even six weeks after the FDA said it was going to decline some pre-submission requests so it could focus all of its energies on pandemic-related diagnostics.  

Still, it’s not quite business as usual. Given its continued “elevated workload” from COVID, the agency says that it will likely review non-COVID IVD pre-submissions “under an extended timeline,” at least for now. The flood of requests for emergency use authorizations (EUA) and pre-EUA submissions is continuing at the rate of about 120 per month, according to the agency. Most of these EUA requests are for in vitro diagnostic tests.

To date, the agency has granted EUA or traditional marketing authorization to over 2,300 medical devices for COVID-19, including nearly 600 in 2022. That’s more than 15 times greater than the total number of EUAs granted for all previous public health emergencies combined.

Look for more information in the upcoming July 2022 issue of Diagnostic Testing & Emerging Technologies.


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