The FDA will discontinue a pilot program aimed at simplifying how manufacturers submit certain 510(k) premarket notifications.
After May 30, 2021, the FDA will no longer accept submissions to the Quality in 510(k) Review program for moderate-risk devices that are well-understood by the agency.
The FDA launched the pilot program in 2018 to determine whether the use of its free eSubmitter software would produce well-organized submissions that FDA staff could review more efficiently. Although it deemed the eSubmitter pilot a success, the agency said last week that it has decided to switch to another submission method using its eSTAR platform.
The eSTAR program provides additional benefits associated with submission preparation using, according to the agency, which said it plans to publish the results of the quality in review pilot.