510(k) Third Party Performance Metrics and Accreditation Status
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 V, 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)).
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The FDA has withdrawn the recognition of third party review organizations listed in the table below:
|Organization||Date of Notice||Notice of Intent Letter||Date of Withdrawal||Withdrawal Letter|
|Accelerated Device Approval Services, LLC||03/12/2021||Notice of Intent to Withdraw Accreditation - (PDF-90KB)||08/13/2021||Withdrawal of Accreditation - (378KB)|
- Third Party Review (Medical Devices)
- List of Devices for Third Party Review
- MDUFA Performance Goals and Procedures, Fiscal Years 2018 through 2022