The 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review are pivotal initiatives by the USFDA to streamline the regulatory process for certain medical devices and diagnostic tools.
Today (21 November, 2024) USFDA's Center for Devices and Radiological Health released updated final guidance "510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review" that provides updated recommendations on the 510(k) Third Party Review Program outlines FDA's current thinking on key aspects of the 510(k) Third Party Review Program and third party review of Emergency Use Authorization (EUA) requests by describing FDA's expectations for the review of 510(k) submissions and EUA requests by third party review organizations.
The 510(k) process is a premarket submission to the FDA to demonstrate that a medical device is substantially equivalent (SE) to a legally marketed predicate device.
The Third Party Review (3P510k) Program allows accredited, FDA-recognized third-party organizations to review certain low-to-moderate risk (Class II) 510(k) submissions.
An EUA is an authorization granted by the FDA to allow the use of unapproved medical products, or unapproved uses of approved products, during public health emergencies.
The 510(k) Third Party Review Program allows accredited organizations to review low-to-moderate risk medical device submissions (510(k)s), enabling FDA to focus on high-risk devices. Similarly, the 3PEUA program involves third parties in reviewing EUA requests, enhancing FDA’s response capabilities during public health emergencies. The guidance details procedures and expectations for:
Determining device eligibility for third-party review.
Processes for recognition and re-recognition of Third Party Review Organizations (TPROs).
Addressing conflicts of interest and quality assurance in reviews.
The objectives of this guidance are:
To describe and distinguish FDA’s expectations for the 3P510k Review Program and 3PEUA review;
To describe the factors FDA will use in determining device type eligibility for review by 3P510k ROs;
To outline FDA’s process for the recognition, re-recognition, suspension, and withdrawal of recognition for 3P510k ROs;
To clarify FDA’s expectations for review under both 3P510k review and 3PEUA review for all stakeholders to ensure confidence and consistent quality of work by Third Party Review Organizations to eliminate the need for routine, substantive re-review by FDA;
To outline FDA’s expectations to prevent conflicts of interest between the Third Party Review Organization(s) and other entities; and
To describe FDA’s expectations regarding the compensation process between the Third Party Review Organization(s) and other entities.
The 510(k) submitter should utilize the electronic Submission Template and Resource (eSTAR) to facilitate the preparation of 510(k) submissions to make sure a submission is administratively complete. The guidance also provides FDA’s recommendations on what should be included in an application to FDA for recognition as a 3P510k RO. The 3P510k RO should inform FDA promptly if they would like to suspend, withdraw, cancel or reduce the scope of their program.
The 510(k) Third Party Review Program and Third Party EUA Review are transformative frameworks that blend efficiency with regulatory rigor. For further details, visit:
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