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FDA Unveils Draft Guidance for SARS-CoV-2 Test Developers to Gain Full Regulatory Approval

NEW YORK – The US Food and Drug Administration has released draft guidance for medical device manufacturers, including SARS-CoV-2 test developers, on how to transition from Emergency Use Authorization to full marketing and regulatory approval. 

Although the FDA has not yet set an expiration date for EUAs, once it comes developers will not be able to distribute their tests without full approval from the agency. In the guidance, the FDA noted that the termination date of EUAs will not be the same date that the US 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 recommended that they include a transition implementation plan addressing how they will deal with devices that have already been distributed. FDA said the plan should include the estimated number of tests currently in US distribution; an explanation of how the manufacturer will dispose of already distributed products if FDA denies the marketing submission; and an explanation of how the manufacturer will deal with previously distributed products if FDA approves the marketing submission.

If the manufacturer proposes leaving the already distributed products in place, "the plan should address the rationale for doing so," the agency said. It should also lay out the process for notifying patients, consumers, healthcare facilities and providers, and distributors of the device's regulatory status. 

For submissions that are denied with already distributed devices left on the market, FDA said the transition plan should include the process and timeline for both restoring those devices to the previously FDA-cleared or approved version and "providing publicly available labeling that accurately describes the product features and regulatory status." It should also include a maintenance plan for distributed devices.

If a marketing submission is approved, manufacturers should provide a process and timeline for providing to users updated labeling or components reflecting changes made to the device, FDA said.

The agency added that if the manufacturer has submitted its test for marketing approval and had it accepted by the FDA before the EUA termination date, the test can continue to be distributed until the agency reaches a final decision, although the labeling must be updated.

For manufacturers that don't intend to seek full approval, tests that have already been distributed may be used for two years after the EUA termination date, or until they expire.

The full guidance document can be downloaded from the FDA's website.