FDA Pilot Program Will Speed 510(k) Reviews of Moderate-Risk Devices

The FDA announced a new pilot program that aims to streamline the review process for some moderate-risk medical devices.

The Quality in 510(k) (Quik) Review Program pilot will allow device sponsors to structure their 510(k) applications through the FDA’s eSubmitter software, with the option to fill out pre-existing fields. The agency said this will enable agency staff to review the information more efficiently and consistently.

The agency projects the program will reduce the maximum review-decision time for eligible sponsors by a full third, from 90 to 60 days.