- April 19, 2022
Dive Brief:
- Toby Lowe, Associate Director for Regulatory Programs in the FDA’s Office of In Vitro Diagnostics and Radiological Health, told a virtual town hall meeting on in mid-April that the Agency is not planning “to take any actions that would leave the American public without the tests that they need.” Lowe emphasized that the FDA recognizes that test manufacturers issued Emergency Use Authorizations (EUAs) during the pandemic need an “appropriate transition period” when the emergency use declaration under section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act that allows the Agency to issue EUAs is no longer in effect.
- FDA is planning to give holders of EUAs for COVID-19 diagnostics and other devices 180 days notice of its intent to terminate their authorizations, in anticipation of U.S. public health emergency declarations no longer being in effect. That draft guidance “proposes that there will be at least a 180-day transition period,” Lowe said during that town hall. “The FDA will finalize that guidance once we review the public comments on the draft.”
Dive Insight:
Since the start of the pandemic, diagnostics companies with COVID-19 tests made available under EUAs have anticipated the day when the U.S. Public Health Emergency (PHE) expires and is not renewed. In the test developer town hall, Lowe said the FDA has been getting a lot of questions from manufacturers about what will happen with tests offered under EUA if the public health emergency (PHE) ends and is not renewed. The COVID-19 public health declaration was issued on January 31, 2020, by then-Health and Human Services Secretary Alex Azar, and has been extended every three (3) months since then. The FDA posted updated information on its website about what happens to EUAs when a PHE ends.
Although the federal pandemic PHE is currently scheduled to end on April 15, it is likely to be extended. Cowen analysts have said they believe the U.S. public health emergency “will likely be extended at least one more time, from April 15 until July 15.” However, Lowe said that while the public health emergency declaration may expire if not extended, it’s important to note the distinction between the PHE determination under section 319 of the Public Health Service Act and the separate declaration under section 564 of the FD&C Act that enables the FDA’s issuance of EUAs. “The EUA declaration under section 564 does not expire and it is not dependent on the extension of the public health emergency declaration,” Lowe told test makers. “The EUA declaration under section 564 continues until the HHS Secretary terminates it. Many of the previous EUA declarations, such as for MERS, Zikea, and Ebola, remain in effect, especially for in vitro diagnostic tests.”
Nonetheless, the FDA is encouraging COVID-19 test makers to actively pursue authorization now through the traditional premarket review process to ensure their testing products will be permitted to be marketed beyond the pandemic. Tim Stenzel, Director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, recommended at a virtual town hall meeting in late March that antigen test developers, in particular, pursue “conversions” of EUAs to fully authorized versions of their products.
“Go ahead and get in line,” the Agency’s testing chief told test makers, adding that first in submissions does not necessarily mean first out depending on “whether any additional work may be needed.” To date, the FDA has only granted a de novo and cleared a 510(k) for COVID-19 molecular tests. “We welcome additional 510(k) submissions for molecular tests. While we have not yet granted full marketing authorization for antigen or serology tests, we are interested in doing so. A de novo submission would be the appropriate pathway for each of those,” the FDA’s website states.
REFERENCE: MedTechDive; 07 APR 2022; Greg Slabodkin