So Your Diagnostic Test Has an EUA: Now What?

The COVID-19 Emergency Use Authorization (EUA) program will end when the pandemic does. Will your market access end as well?

The first De Novo authorization of a COVID-19 diagnostic test, the BioFire panel, has opened the door for similar tests to seek 510(k) clearance. This news, along with declining case numbers in the U.S. due to the vaccination campaign, has helped spur increasing interest among test developers in transitioning from Emergency Use Authorization (EUA) to traditional submissions. COVID-19 diagnostics are anticipated to remain useful even after the pandemic has abated; however, traditional submissions will be required to offer those diagnostics for sale.

Traditional submissions require significantly more samples, more data, and more paperwork than the U.S. Food & Drug Administration (FDA) requires for an EUA submission. This is by design — EUA submission requirements were crafted to give developers the ability to bring quality tests to market quickly. The current EUA program will end when the government lifts the COVID-19 emergency declaration. After that, no tests with EUA approval will be allowed to remain on the market.

Test developers have had a rare opportunity under the COVID-19 EUA regulatory paradigm to gather data needed for their traditional submissions while simultaneously selling their products on the market. This unique set of circumstances can help offset the overall costs of gathering the data necessary for a De Novo or 510(k) submission. FDA has indicated that additional guidance for converting EUA submissions to traditional submissions is in preparation.

Meanwhile, FDA is receiving submissions for the various types of COVID-19 tests (antigen, antibody, etc.). Through this process, FDA is gathering data to draft guidance for the diverse developer community that will be applicable to programs both large and small. As such, developers may benefit from partnering with those with experience in traditional submissions to develop a COVID-19 diagnostics regulatory strategy and submission package that reflects the evolving regulatory landscape.

How Exponent Can Help

Exponent's multidisciplinary team of in vitro diagnostic, medical device, and pharmaceutical industry professionals develop safety information for products and processes that complies with pertinent standards, regulations, and best practices. With expertise in analytic and clinical assessments, human factors, Software as a Medical Device (SaMD) regulations, artificial intelligence, CLIA compliance, quality system establishment, and FDA assessments, Exponent can assist in reviewing submission packages, auditing labs, or performing due diligence and independent review of the validation/technical design of the assay, instrument, or collection kit. Our offerings also include reviewing diagnostic data to assess the completeness of the package for submission as well as support for regulatory filings including EUAs, 510(k)s, and De Novos.