The U.S. Food and Drug Administration (FDA) this week published a guidance document that outlines a transition plan for IVD tests issued COVID-19 emergency use authorizations (EUAs).
“FDA recommends that manufacturers of devices authorized under EUAs plan their post-EUA regulatory and disposition strategies now,” the agency said in the document.
The recommendations give IVD companies time to execute their strategic plans. HHS intends to publish an advance notice of termination of each EUA declaration 180 days before the day on which the EUA declaration is terminated, the FDA said, adding, “When an EUA declaration is terminated, the agency intends to promptly publish notice of termination of the associated EUAs in the Federal Register and an explanation of the reasons for the termination.”
Based on current COVID-19 trends, the U.S. Department of Health and Human Services (HHS) is planning for the emergency declaration to expire at the end of the day on May 11; HHS had declared a public health emergency on January 31, 2020, in response to the outbreak of the SARS-CoV-2 virus.
As of Tuesday, the FDA had granted EUA for 445 tests and sample collection devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). These include 300 molecular tests and sample collection devices, 84 antibody and other immune response tests, 60 antigen tests, and one diagnostic breath test.
The new guidance is “mostly consistent with the FDA’s previous comments on the transition away from EUAs, which is reassuring for companies with products under such authorization,” wrote Mara Aspinall and Liz Ruark in Sensitive & Specific: The Testing Newsletter. However, there are important implications for IVD companies and laboratories, they noted, including how quickly the agency will process COVID EUA-to-marketing-approval applications and whether the volume of applications from EUAs slows the process for other diagnostic test approvals.
The agency has scheduled a webinar on April 18 to outline its guidance and transition plan.
“Given the magnitude of the response to the COVID-19 pandemic, including the number of devices issued EUAs, FDA recognizes that stakeholders may need time to adjust after the termination of the device EUA declarations to help ensure an orderly and transparent transition to normal operations,” the agency said in its new guidance document.
It developed the guidance to help avoid disruption in device supply while facilitating compliance with applicable FD&C Act requirements after the termination of the EUA declaration.
“FDA believes that by issuing this guidance in draft with a proposed transition policy and requesting public comment (including from manufacturers of EUA-authorized devices), the agency has satisfied the requirement to consult with manufacturers, while also efficiently managing agency resources,” the FDA said in its guidance.
Going forward, for manufacturers of devices authorized under an EUA that are seeking the required marketing authorization for their devices, the agency has provided recommendations in the new guidance document. “FDA recommends that these manufacturers submit their marketing submissions to FDA with sufficient time for the submission to be accepted ... before the EUA termination date,” it said, among other recommendations.
