FDA Re-Opens Door to Pre-Submission Requests for Non-COVID-19 IVD 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 all in vitro diagnostics (IVD), 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.   

Not Quite a Return to Normalcy

The demand for medical devices during the COVID-19 pandemic “has far exceeded anything we have seen in previous public health emergencies,” according to the official FDA announcement. The resulting “significant increase in workload has adversely impacted our premarket review times for both COVID and non-COVID medical devices and our ability to meet all requests for pre-submission meetings.”

But now the FDA will once more accept all non-COVID-19 pre-submissions. Still, it is 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.

Meanwhile, the FDA said that the flood of requests for emergency use authorizations (EUAs) and pre-EUA submissions is continuing at the rate of about 120 per month. 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 is more than 15 times greater than the total number of EUAs granted for all previous public health emergencies combined.

Beyond EUA

The agency also indicated that it has started receiving submissions from COVID-19 test makers seeking to transition from EUA to full clearance or approval status. This is something the FDA has been urging companies to consider for more than a year. “We recommend that developers consider their long-term interests as far as whether they want to be on the market long term,” noted FDA director of in vitro diagnostics and radiological health Tim Stenzel during a recent agency town hall briefing, adding that companies can start working on 510(k) submissions for molecular tests or de novo submissions for antigen tests.

FDA Prepares for Future Surges

Meanwhile, the FDA is looking forward to ensure laboratories are better prepared for future testing surges like the one generated by the COVID-19 pandemic. During the town hall meeting, Stenzel also discussed a memorandum of understanding the agency signed last month with the Centers for Disease Control and Prevention (CDC), American Clinical Laboratory Association (ACLA), College of American Pathologists (CAP) and five other associations to collaborate on enhancing laboratory testing surge capacity before and during public health emergencies (PHEs). The basic strategy: Bolster testing capacity by having the CDC identify and seek to enlist academic medical centers and private clinical laboratories that have the capacity to participate in future emergency responses.

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Here are some of the key new FDA EUAs and clearances that were announced in May and early June, 2022:

New FDA Emergency Use Authorizations (EUAs) & Approvals

Manufacturer(s)	Product
DxLab	EUA for molecular DxLab COVID-19 RT-LAMP test run on company's DxHub instrument
LG Chem	EUA for AdvanSure SARS-CoV-2 IgG(S1), an ELISA-based SARS-CoV-2 antibody test
Angle	Clearance for Parsortix cell sorting system for isolation of circulating metastatic breast cancer cells for liquid biopsy testing
LabCorp	EUA for Labcorp Seasonal Respiratory Virus RT-PCR Test for simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza viruses A and B, and respiratory syncytial virus, including for OTC use
Nexus Medical Labs	EUA for High Throughput SARS-CoV-2 Assay
Abbott	EUA for ID Now COVID-19 2.0 rapid point-of-care test
Becton Dickinson	510(k) clearance for MX molecular diagnostics module and triplex assay for chlamydia, gonorrhea, and trichomonas