Quality in 510(k) Review Program Pilot

Quality in 510k  review program pilot (RPP) gives an different method to submit a 510k to the FDA via the eSubmitter software. ( For specific device types) On April 26, 2021, the FDA announced the decision to conclude the Quality in 510(k) Review Program Pilot. Quality in 510(k) Review Files will no longer be accepted by the FDA after May 30, 2021. The applicable medical device codes for this programme were also published by FDA.

The Quality in 510(k) Review Program pilot’s goal is to assess the program’s effectiveness and determine whether using the FDA’s free eSubmitter software will result in well-organized submissions that can be reviewed more quickly, thereby promoting timely access to high-quality, safe, and reliable 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 eSubmitter template “CDRH: Non-In Vitro Diagnostic Device – 510(k).”

Refuse to accept (RTA) reviews are not done if the application qualifies for the Quality in 510(k) Review Program pilot. The review should involve audience participation. The FDA is expected to make a final determination for 510(k)s submitted as part of the Quality in 510(k) Review Program pilot within 60 days of receipt.