FDA Update: Third Party Reviews – FDA Cancels Certification

FDA Cracking Down On Third Party Review Organization Accreditations of 510ks.  Non-compliance Considered a Threat to Public Health and Safety…

Over the years, since FDA had incorporated the third party review for the 510(k), mdi has periodically attempted to use third party review as requested by our clients to try to get a faster 510(k) clearance.  Unfortunately, the extra payment to get the “accelerated” review has not been worth the money or the time. Our experiences with several third party reviewers has not favorable. We had an unfortunate experience with ADAS.

On August 13, 2021, the U.S. Food and Drug Administration (FDA) withdrew recognition of Accelerated Device Approval Services (ADAS) as an accredited (recognized) third party review organization under the 510(k) Third Party Review.

The FDA determined that Accelerated Device Approval Services (ADAS) is substantially not in compliance with the requirements of the 510(k) Third Party Review Program, which is established in section 523 of the Federal Food, Drug, and Cosmetic Act, and has failed to act in a manner consistent with the purposes of the 510(k) Third Party Review Program.

The Accredited Persons Program was created by the FDA Modernization Act of 1997 (FDAMA) to improve the efficiency and timeliness of the FDA’s 510(k) process. Under the program, the FDA accredits third parties (or accredited persons, now known as third party review organizations) that are authorized to conduct the primary review of 510(k)s for eligible devices. Under MDUFA IV, the FDA committed to publishing the performance of individual accredited Third Parties with at least five completed submissions on this page (for example, rate of not substantially equivalent (NSE), average number of holds, average time to substantially equivalent (SE)).

Accreditation Status

A list of accredited third party review organizations is available on the Current List of FDA-Recognized 510(k) Third Party Review Organizations page.

Under section 523 of the Federal Food, Drug, and Cosmetic Act, the FDA may suspend or withdraw accreditation of any third party review organization, after providing notice and an opportunity for an informal hearing, when the accredited third party is substantially not in compliance with the requirements of the section, or poses a threat to public health, or fails to act in a manner that is consistent with the purposes of the section.

The FDA has withdrawn the recognition of third party review organizations listed in the table below:

Questions?

mdi will continue to monitors the FDA’s recommendations and warnings regarding third party review requirements, updates, and warnings in regard to 510(k)s. For more information on this FDA policy please contact mdi at: [email protected].