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Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), “the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological or nuclear (CBRN) threat agents when there are no adequate, approved, and available alternatives.”

Since February 4, 2020, FDA has approved 204 Covid-19 tests under the Emergency Use Authorization (EUA) process. This includes 167 molecular tests, 35 antibody tests, and only 2 antigen tests (as of August 8, 2020). Interestingly, starting in June 2020, FDA has revoked EUA approval from 89 of those tests for several reasons. In most cases, the removals were due to ineffectiveness. FDA concluded that based on the risks to public health from false test results, revocation was appropriate to protect the public health or safety. Many of these removals were also proven by testing performed by FDA and other government agencies.

The FDA issued a guidance for the development of in vitro diagnostic tests during this public health emergency in February 2020. The guidance has been modified several times as more information has become available. FDA has summarized the expected performance of the tests in these guidance documents, consistently stating that the performance of these tests is described by their “sensitivity,” or their ability to identify those with antibodies to SARS-CoV-2 (true positive rate), and their “specificity,” or their ability to identify those without antibodies to SARS-CoV-2 (true negative rate). Unfortunately, it comes to light that the companies stated performance is either incorrect, validated with too few samples, or has human factors usability failures.

MEDIcept has assisted many companies with their COVID-19 in vitro diagnostic tests. We are happy to say that none of the companies we have helped have been removed from EUA and all the tests have been deemed effective. We know the FDA personnel involved in EUA process and speak with them weekly; at MEDIcept, our clients trust us to help them get through the process effectively and efficiently.

If you would like more information on COVID-19 medical devices or the EUA process, please contact the regulatory experts here at MEDIcept.

For additional information, please contact Susan Reilly at SReilly@MEDIcept.com.