The FDA today issued final guidance today for its 510(k) third party review program in an effort to channel agency staff time toward reviewing more complex devices.
The new guidance clarifies expectations for third party review organizations (3P510k review organizations) of how to meet the FDA’s standard for 510(k)-eligible product review and could eliminate the need for routine, duplicative re-reviews of certain information by FDA staff, according to the agency. The FDA also said it is updating the list of devices eligible for review under that program.
The third party review is designed to enable the FDA to focus its internal scientific review resources on higher-risk and complex devices, sending FDA-equivalent reviews of low- to moderate-risk and less complex devices to 3P510k review organizations. Greater use of the third party review program can reduce agency review times to 30 days or less, the FDA noted.
The program also provides manufacturers an efficient, consistent and predictable process to request review of 510(k) submissions by accredited, FDA recognized organizations, according to the agency.
Specifically, the final guidance:
- Describes the factors the FDA uses to determine device type eligibility for review by third party review organizations.
- Outlines the process for the recognition, re-recognition, suspension and withdrawal of recognition for 3P510k review organizations.
- Seeks to ensure consistent quality of work among 3P510k review organizations.