With the public health emergency (PHE) coming to an end, labs and companies that have secured Emergency Use Authorization (EUA) clearance for COVID-19 tests and other diagnostic products face a stark choice: get full regulatory approval, or take the product off the market. The FDA recently issued a new guidance document for those that choose the first option.
EUA clearance won’t expire immediately when the PHE ends on May 11, the FDA guidance explains. The U.S. Department of Health & Human Services will provide plenty of advance notice before the official EUA termination date. Companies that want to keep marketing EUA devices will have to prepare an FDA marketing submission before that termination date arrives. As part of that submission, companies should also include a Transition Implementation Plan for dealing with devices already distributed in the event of either a positive or negative ruling on the marketing submission. The guidance specifies the information that plan should list.
The FDA acknowledges that transitioning to full marketing approval may take time. The guidance indicates that the FDA doesn’t intend to object to the continued distribution of devices that are still undergoing review after their EUA ends, as long as the agency has previously accepted marketing submission for the device. However, companies that don’t make a marketing submission by the EUA termination date will have to stop marketing their devices on that date.
Get the full story, along with other recent FDA news, in our May 2023 Diagnostic Testing & Emerging Technologies issue, posted in advance of PDF publication.