FDA finalizes guidance on 510(k) third-party reviews

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday finalized guidance to assist manufacturers in using an alternative process for getting low- to moderate-risk devices authorized through the third party 510(k) review program (3P510K). The guidance also describes the use of third-party review organizations for emergency use authorization (EUA) requests.

According to FDA, the guidance revises a draft version that was released for comment last year by clarifying the relationship between 510(k) review organizations and EUA third-party review organizations and clarifying conflicts of interest requirements for personnel of third-party review organizations. (RELATED: FDA updates third party 510(k) guidance, Regulatory Focus 21 December 2023).

In its latest performance report for the program, FDA said that 68 third-party 510(k) submissions were accepted in FY 2024, a decrease from the 77 accepted in FY 2023. Seven organizations are accredited to conduct third-party reviews, which are meant to free FDA’s limited resources to review more complex devices.

The guidance states that a 3P510k review organization (RO) should be an independent organization outside the federal government that is not owned or controlled by a device manufacturer, supplier, or vendor. These groups should also have no organizational, material, or financial ties with a manufacturer, supplier, or vendor. Such organizations must also treat information received in submissions as proprietary.

It also outlines expectations for third-party reviews of 510(k) submissions and EUA requests. The guidance states that “before reviewing a 510(k) submission, a 3P510k RO should determine whether they have the expertise to review the device type and whether that device type is eligible for 3P510k review based on a review of the product code and classification database or the FDA Third Party Review public website.”

In addition, the review memo should address how the device works and the information the submitter provided to demonstrate that the product is “substantially equivalent” to a legally marketed device.

For an EUA request, the memo should address what information the submitter provided to demonstrate that it is “reasonable to believe that the product may be effective for the specified use.”

The guidance also addresses the process for recognizing, suspending, and withdrawing recognition for 3P510k review organizations and compensation to third-party review organizations.

FDA's current thinking on leveraging the International Medical Device Regulators Forum's (IMDRF) documents for the 3P510k review program is also addressed.

Under the 3P510K program, FDA is permitted to recognize third parties to review certain low-to-moderate medical device submissions and recommend initial classifications. These reviews are conducted under the oversight of the CDRH.

Final guidance

FDA finalizes guidance on 510(k) third-party reviews

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