Current List of FDA-Recognized 510(k) Third Party Review Organizations
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
see related
Database updated June 29, 2020

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. 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.
AABB
Accelerated Device Approval Services, LLC
Biomarkers and Diagnostics Consulting, LLC
CENTER FOR MEASUREMENT STANDARDS OF INDUSTRIAL
COLA, Inc.
New York State Department of Health
REGULATORY TECHNOLOGY SERVICES, LLC
THIRD PARTY REVIEW GROUP, LLC
top of page   
-
-