Brandy Guarda, Regulatory Analyst in Washington, D.C., contributed to the drafting of this post.
On September 27, 2022, the U.S. Food and Drug Administration (FDA) updated its COVID-19 Test Policy Guidance to encourage test developers to pursue full marketing authorization as opposed to Emergency Use Authorizations (EUAs). The agency will prioritize EUA reviews for:
- Diagnostic tests that are likely to have significant benefits for public health (such as those that employ new technologies);
- Diagnostic tests that are likely to fulfill an unmet need (such as diagnosing infection with a new variant or subvariant);
- Supplemental EUA requests for previously authorized tests when the request is intended to fulfill a condition of authorization or includes a modification that will significantly benefit public health or fulfill an unmet need; and
- Tests for EUA requests from (or supported by) a U.S. government stakeholder, such as tests funded by the Biomedical Advanced Research and Development Authority or the National Institutes of Health’s Rapid Acceleration of Diagnostics.
Note: There has been no movement on the draft Transition guidances since comments closed in March 2022, but we continue to monitor closely for any updates on this guidance. We recommend that test developers work with counsel to evaluate these new EUA guidelines and how their diagnostic tests may fit into the remaining prioritization categories. It will be essential to develop persuasive cover letters for FDA that hone in on the most innovative aspects of their tests and how they will advance public benefit, and to highlight these features of tests in early correspondence with the agency.