For specific device types, the Quality in 510(k) Review Program Pilot offers an alternative means of submitting a premarket notice (510(k) to the FDA by using the e-Submitter software to prepare the submission. The FDA announced its intention to end the quality in 510(k) review program pilot on april 26, 2021. quality in 510(k) review files will no longer be accepted by the FDA after May 30, 2021.
The FDA also provided a list of the medical devices and product codes that were applicable to this programme. The pilot’s goal is to assess the quality in 510(k) review program to see if using the FDA’s free e-Submitter software would result in well-organized submissions that can be evaluated more quickly, therefore promoting timely access to safe, effective, and high-quality medical devices.
The eligibility factors for the Quality in 510(k) Review Program Pilot
- The device code must be there in FDA list.
- The device is not a combination product.
- The lead Center for the device is the FDA’s Center for Devices and Radiological Health (CDRH).
- The submission was constructed with the e-Submitter template “CDRH: Non-In Vitro Diagnostic Device – 510(k).”
The refuse to accept (RTA) review will not be performed if the application is eligible for the Quality in 510(k) Review Program pilot. The review will most likely be interactive. The FDA is expected to make a final decision on 510(k)s submitted as part of the Quality in 510(k) Review Program pilot within 60 days of receipt.