New FDA Pilot Program Will Speed 510(K) Reviews for 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 sponsors of the devices in question to submit their 510(k) applications using the FDA’s eSubmitter software, with the option to fill out pre-existing fields. This will enable FDA staff to review the information in a more efficient, consistent manner, according to the agency.

The agency projects the program will reduce the maximum review-decision time for eligible sponsors a full third, from 90 to 60 days. All statutory and data requirements will remain unchanged, with sponsors still required to demonstrate the devices are substantially equivalent to a predicate device, according to the agency.

About 40 product codes will be eligible for the pilot program, including products such as electronic stethoscopes, surgical wire and certain ophthalmological cameras.

The agency plans to assess whether to continue and expand the program after the pilot period ends in 2019.

FDA Commissioner Scott Gottlieb said the new process will allow the agency to put more time and resources into evaluating applications for devices that pose the highest potential risks to patients.

“Simplifying the process to submit applications is part of the FDA’s ongoing effort to ensure that we’re giving patients more efficient access to safe, effective, and high-quality medical devices,” he said. — Zack Budryk