For the past two years, FDA has been working to improve the 510(k) Third Party Review Program. This program is meant to delegate the review of certain 510(k) submissions, freeing FDA’s limited resources to focus on the review of more complex devices and those that present a greater risk to users. While this seems like a great program in theory, since its introduction in __ in practice it has been greatly underutilized due to FDA routinely re-reviewing the submission. In September of 2018, FDA issued a draft guidance on an updated Third Party Review Program, which was finalized on March 12, 2020. The final version is largely unchanged from the draft. This post will focus on notable changes. For a more detailed overview of the Program overall, visit our prior blog post, here.
Overview of the Prior Third Party Review Program
FDA’s Third Party Review Program, formerly known as the Accredited Persons Program, allows sponsors to submit 510(k) applications for devices with eligible product codes to a Third Party Reviewer, who uses FDA criteria to evaluate the submission.
The Final Guidance, like the draft, limits eligibility for Third Party Review to certain device types which generally present a lower risk to users. It also outlines the same factors it will consider when determining eligible devices: (1) the risk profile of the device, (2) the extent to which a Third Party Reviewer would have access to the information needed to make a well-informed decision, (3) the extent to which the review requires multifaceted interdisciplinary expertise, and (4) the extent to which post-market safety data should be considered. Product codes eligible for Third Party Review are identified on FDA’s product code classification database.
After its substantive review, the Third Party Reviewer sends the submission to FDA with a recommendation that the device is Substantially Equivalent (SE) or Not Substantially Equivalent. FDA has thirty days to make a final determination. Under the prior program, however, FDA regularly re-reviewed all or part of the 510(k) submission before making a final determination, essentially eliminating the program’s efficiency. FDA accepted 75 Third party 510(k) submissions in fiscal year 2018 and 78 in fiscal year 2019.
Overview of FDA’s New 510(k) Third Party Review Program
As noted above, FDA’s final guidance is largely unchanged from the draft. The most notable, non-substantive change is abbreviating the program as the “3P510k” Review Program, previously the “3P Review Program.” Not only is this a mouthful, the reference to a 510(k) submission as “510k” makes many in the industry, the author included, cringe. FDA provided no explanation for the change in name, or dropping the parentheses in 510(k).
A more substantive change is the expansion of international standards with which the 3P510k Review Organization can comply and still “be in compliance with most FDA 3P510k Review Organization requirements and meet FDA’s recommendations” in the guidance document. While FDA does not elaborate on what it means by “most” requirements, it is notable that under the final guidance, 3P510k Review Organizations and Reviewers can comply with the Medical Devices Single Audit Program (MDSAP) and the International Medical Device Regulators Forum’s Good Regulatory Review Practices; whereas the draft only referenced reliance on standards in MDSAP.
FDA’s Final Guidance elaborates on the draft’s reference to forum shopping, explaining that 510(k) Submitters are not permitted to provide substantially the same submission to multiple 3P510k Review Organizations to find the one most likely to recommend an SE determination. The final draft also adds trade secrets to the description of confidential information a 3P510k Review Organization is expected to protect. Disclosure of confidential information or trade secrets is prohibited under the 3P510k Review Program and could result in a suspension or withdrawal of recognition of the organization.
When FDA issued the draft a year and a half ago, we expressed cautious optimism that the revamped program would provide a meaningful alternative to the 510(k) submission process for certain devices. While that outcome is not yet clear, we look forward to tracking the use of this program and will keep our readers updated with any additional developments.