The U.S. Food and Drug Administration (FDA) has launched its new Quality in 510(k) (Quik) Review pilot program to speed up the regulatory clearance of certain moderate-risk medical devices.
The initiative will allow companies to use the agency's free eSubmitter software to submit 510(k) applications by completing a downloadable electronic form, providing the FDA with product information in a streamlined format.
The agency has already identified approximately 40 product codes that are eligible for this pilot. It expects that the new process could reduce decision time for most products in the Quik Review program from 90 days to 60 days.
Statutory and data requirements for device submission will remain the same.
