FDA Withdraws Recognition of a Third Party Review Organization
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.
Learn more about the Third Party Review Program
Questions?
If you have questions about the withdraw or the Third Party Review Program, contact the Division of Industry and Consumer Education.
|
