FDA updates third party 510(k) guidance

The US Food and Drug Administration (FDA) has published a draft guidance that updates a 2020 final guidance on its third party 510(k) review program (3P510K). Besides pointing out new updates to the program, it also details how the agency can use third party reviewers to evaluate emergency use authorization (EUA) requests, as mandated by Congress.

Under the 2020 3P510K guidance, FDA is allowed to recognize third-party reviewers who can review 510(k) premarket submissions to recommend an initial classification of certain low-to-moderate risk devices. The updated guidance also adds that the agency can contract with third-party reviewers to perform similar reviews of EUA devices. Such reviews, however, are not new, as FDA has worked with such organizations on third party reviewed EUAs (3PEUA) during the COVID-19 pandemic. FDA notes that the draft guidance is not in effect and will supersede the 2020 guidance when finalized.

FDA notes that it was inundated with EUA requests for COVID-19 diagnostics tests during the pandemic, which led it to focus on tests that had a new intended use. At the same time, it was also receiving EUA requests for tests that it had experience with. To alleviate its resources, FDA contracted with third party 510(k) EUA review organizations (3PEUA RO) to review more than one hundred in vitro diagnostic EUA requests.

With that experience in mind, Congress passed the Consolidated Appropriations Act, 2023 last year, which explicitly detailed FDA’s authority to use third party organizations to review EUA requests, and directed the agency to develop the new draft guidance that includes details such as how to compensate such organizations and address issues such as data sharing and conflicts of interest.

The new guidance states the expectations that FDA has for the two different third party review pathways. It also details how the agency will determine what devices are eligible for third party review, its expectations when a review is considered substantial, how it plans to recognize or withdraw recognition for a third-party 510(k) review organization (3P510K RO) and how it plans to compensate them.

Furthermore, the guidance updates work the International Medical Device Regulators Forum (IMDRF) has done since previous guidance that can be leveraged by FDA to use for third party 510(k) reviews.

“The IMDRF Good Regulatory Review Practices (GRRP) working groups developed documents that provide the fundamental building blocks of third party review that can be applicable to submissions such as 510(k) submissions and EUA requests by providing criteria for reviewer competence, training, and conduct, and, for organizations, the expectations for entities (“Conformity Assessment Bodies” or CABs) that perform regulatory reviews,” said the guidance. “These documents focus on expectations for CABs and the individuals CABs engage to perform regulatory reviews and other related functions under the respective medical device legislation, regulations, and procedures required in its regulatory jurisdiction.”

FDA says third party reviewers who are in compliance with relevant GPP documents are likely to be in alignment with most of its own requirements outlined in the guidance and may be able to leverage their existing documents in their appliance so they may not need to generate new documentation for the agency.

Third party review program draft guidance

FDA updates third party 510(k) guidance

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