The FDA said it intends to review “only a small subset” of new EUA submissions, encouraging test makers to seek regulatory approval through de novo classification or 510(k) clearance pre-market review pathways.
The policy update comes a week after the U.S. Department of Health and Human Services Office of Inspector General released a study that found the FDA’s EUA process authorized problematic tests and frustrated diagnostics developers.
The FDA’s “calculated decisions to increase availability of COVID-19 testing … often came at a potential cost to test quality,” the report said. “… FDA’s decision to accept all EUA requests resulted in a record number of submissions — often low-quality and from developers lacking experience with FDA’s processes.”
The study included recommendations for the EUA process and said the FDA agreed with all of them.
The FDA will continue to offer its support and expertise to help diagnostics developers make accurate and reliable tests and ensure access for patients, FDA Center for Devices and Radiological Health Director Dr. Jeff Shuren said in a statement.
“Testing remains one of the key pillars in combatting the COVID-19 pandemic,” Shuren said in a statement. “Taking into account the current status of manufacturing capacity and consumer access given the administration’s important investments in tests, for most new tests, shifting to traditional premarket review would best meet the public health needs at the current stage of the COVID-19 public health emergency.”
The FDA has issued EUAs for more than 430 COVID-19 tests. Tests with pending EUA authorization requests will remain on that pathway.
Which COVID-19 tests will the FDA consider for emergency use authorization?
The FDA said it will focus on EUA requests and supplemental EUA requests from “experienced developers” for:
- Diagnostic tests likely to have a significant public health benefit, such as new technologies;
- Diagnostic tests likely to fulfill an unmet need, such as diagnosing infections with a new variant or subvariant;
- Supplemental EUA requests for previously authorized tests when the request aims to fulfill a condition of authorization or includes a modification that will significantly benefit public health or fulfill an unmet need;
- And tests for which the EUA request is from or supported by a U.S. government stakeholder, including the Biomedical Advanced Research and Development Authority (BARDA) or the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx).