Posted:
The FDA’s August 4, 2025 update to the Accredited Persons list shows eight organizations currently recognized to conduct third-party 510(k) reviews for select medical devices, including hearing aids. This allows eligible devices to be reviewed by accredited organizations rather than FDA staff, potentially reducing clearance timelines.
Authorized third party reviewers includes Regulatory Technology Services and BeanStock Consulting. The FDA lists eligible devices by product code, which can be checked in the FDA’s product code database to confirm whether a specific device, such as a digital hearing aid, qualifies for third-party review. Check the list by clicking here.
