The U.S. Food and Drug Administration has updated its COVID-19 test policy to ensure continued access to tests while encouraging the transition of these important public health tools to traditional premarket review pathways. The updated policy describes the FDA’s intent to review only a small subset of new emergency use authorization (EUA) requests for diagnostic tests and encourages developers of all test types interested in marketing authorization to pursue authorization through the de novo classification or 510(k) clearance pre-market review pathways.

“Testing remains one of the key pillars in combatting the COVID-19 pandemic,” says Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “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 will continue to offer support and expertise to assist with the development of accurate and reliable tests, and to facilitate continued access to tests for all Americans.” 

Since the start of the pandemic, the FDA has adapted its regulatory approach and test policy to address the public’s testing needs and has worked closely with test developers to adjust as those needs have changed. These efforts have helped increase testing capacity and broaden public access to rapid tests, including those purchased over-the-counter (OTC). The U.S. currently has the capacity for authorized manufacturers to produce hundreds of millions of tests per month, although the number of tests available for use at any given time will depend on demand and other factors, according to the agency.

To date, more than 430 distinct COVID-19 tests have been issued EUAs. The available information indicates that these tests are providing sufficient testing capacity for COVID-19 tests throughout the United States. Recognizing the current testing capacity, at this time, the agency believes most future submissions are best suited for traditional premarket review pathways. Therefore, the FDA is revising its test policy to update the types of COVID-19 tests for which the agency intends to review EUA requests and discuss the use of the traditional premarket review pathways for COVID-19 tests. Tests for which EUA authorization requests are pending prior to this announcement will remain in the queue. 

Moving forward, the FDA generally intends to focus its review on EUA requests and supplemental EUA requests from experienced developers for:  

  • Diagnostic tests that are likely to have a significant benefit to 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
  • Tests for which the EUA request is from (or supported by) a U.S. government stakeholder, such as tests funded by the Biomedical Advanced Research and Development Authority (BARDA) or the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx).

The FDA says it believes these priorities are appropriate to address the public health needs at the current stage of the COVID-19 public health emergency and may adjust these priorities as public health needs change. The FDA says it encourages test developers to consider these priorities and to otherwise shift their focus to traditional premarket review pathways for tests already authorized under EUA and new tests of the same types as those already available under EUA.

To date, the agency says it has facilitated the traditional premarket review of COVID-19 diagnostic tests, one through de novo classification and others of the same type utilizing the 510(k) clearance process.