Food and Drug Administration Draft guidelines published Provide medical device manufacturers (including COVID test developers) with information on how to transition from emergency use authorization to full marketing and regulatory approval.

Although the FDA has not set an expiration date for the EUA, once it expires, developers will not be able to distribute their tests without full approval from the agency. In the guidance, the FDA pointed out that the EUA’s end date is different from the date when the Department of Health and Human Services declared the end of the COVID-19 public health emergency.

If manufacturers intend to seek full approval for their testing, the FDA recommends that they include a transitional implementation plan that addresses how they will dispose of devices that have already been distributed. The FDA stated that the plan should include the estimated number of tests currently distributed in the United States; if the FDA rejects the marketing submission, an explanation of how the manufacturer will handle the already distributed product; if the FDA approves the marketing application, how the manufacturer will handle the previously distributed product explanation of.

The agency stated that if the manufacturer proposes to leave the already distributed product in place, “the plan should explain the reason for doing so.” It should also outline the process for notifying patients, consumers, medical institutions and suppliers, and distributors of the regulatory status of the device.

For submissions that have been rejected for devices that have been distributed on the market, the FDA stated that the transition plan should include restoring these devices to previously FDA-approved or approved versions and the process and timetable function of “providing a public label that accurately describes the product” And regulatory status. “It should also include a maintenance plan for distributed equipment.

The FDA stated that if the marketing application is approved, the manufacturer should provide a process and timetable to provide users with updated labels or components that reflect changes to the device.

The agency added that if a manufacturer has submitted its marketing authorization test and is accepted by the FDA before the EUA end date, the test can continue to be distributed until the agency makes a final decision, but the label must be updated.

For manufacturers who do not intend to seek full approval, the tests that have been distributed can be used within two years of the EUA end date, or until they expire.

This story first appeared in our sister publication Genomeweb.