The Food and Drug Administration has released draft guidance for medical device manufacturers, including developers of COVID tests, on how to move from emergency use authorization to commercial approval and full regulatory.
While the FDA has yet to set an expiration date for the EUAs, once that happens, developers won’t be able to distribute their tests without full agency approval. In the guidelines, the FDA noted that the EUA end date will not be the same date as the date the Department of Health and Human Services declares the COVID-19 public health emergency over.
If manufacturers intend to seek full approval for their tests, the FDA has recommended that they include a transition implementation plan outlining how they will deal with devices that have already been distributed. The FDA said the plan should include the estimated number of tests currently in distribution in the United States; an explanation of how the manufacturer will dispose of already distributed products if the FDA denies the marketing application; and an explanation of how the manufacturer will treat previously distributed products if the FDA approves the marketing application.
If the manufacturer offers to leave already distributed products in place, “the plan should address the rationale for doing so,” the agency said. It should also define the process for notifying patients, consumers, healthcare establishments and providers, and distributors of the regulatory status of the device.
For rejected submissions with previously distributed devices left on the market, the FDA said the transition plan should include the process and timeline for both restoring these devices to the previously approved or FDA approved version and “providing publicly available labeling that accurately describes the product’s functionality and regulatory status. ” It should also include a maintenance plan for the distributed devices.
If a marketing submission is approved, manufacturers must provide a process and schedule to provide users with updated labeling or components to reflect changes to the device, the FDA said.
The agency added that if the manufacturer submitted their test for market approval and had it approved by the FDA before the EUA end date, the test can continue to be distributed until that time. that the agency make a final decision, although the labeling needs to be updated.
For manufacturers who do not intend to seek full approval, tests that have already been distributed can be used for two years after the EUA end date, or until they expire.
This story first appeared in our sister post, Genomeweb.