Current List of FDA-Recognized 510(k) Third Party Review Organizations



Database updated July 22, 2024

This page provides information on organizations recognized by FDA to review submissions under the 510(k) Third Party Review Program (formally, the Accredited Persons Program) and the devices they may review. Product codes eligible to review by a specific 3P510k Review Organization are listed under the following regulations. Devices eligible for review by 3P510k Review Organizations are limited to the product codes shown on the list of eligible devices. You can look up a given product code in the product code database, browse by 3P510k review organization in the list below or browse by device area to confirm eligibility of your device.

As of August 13, 2021, Accelerated Device Approval Services, LLC (ADAS) is no longer recognized to conduct 510(k) Third Party Reviews. For details, see the Accreditation Status section on the 510(k) Third Party Performance Metrics and Accreditation Status page.

AABB

BeanStock Consulting

CENTER FOR MEASUREMENT STANDARDS OF INDUSTRIAL

COLA, Inc.

Global Quality and Regulatory Services

REGULATORY TECHNOLOGY SERVICES, LLC

THIRD PARTY REVIEW GROUP, LLC

COLA, Inc.

9881 Broken Land Parkway

Suite 200

Columbia MD 21046

ThirdParty@cola.org