FDA has launched a new pilot program for a “Quick Review“ of 510(k) of certain medical devices, by using the eSubmitter software to format the submission. The devices that qualify for this quick review, as shown on list below, are moderate risk devices that are considered to be well-understood by the FDA. With the quick review program, 510(K)s are reviewed by FDA in 60 days instead of 90 days.

What are the eligibility criteria?

• The device’s primary product code is listed below.

• The device is not a combination product (such as a drug-device or biologic-device combination).
• 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 “non-In Vitro Diagnostic Device – 510(k).”

 How to prepare a 510(k) for the Quick Review Program?

510(k)s submitted as part of the Quick Review Program pilot must be constructed using the eSubmitter template entitled “CDRH: Non-In Vitro Diagnostic Device – 510(k).”

The eSubmitter asks for the same information typically requested in a Traditional 510(k). After it is constructed, the eSubmitter will format the submission into a ZIP file. This should be copied to a CD, DVD, or USB drive.

The cover letter of the 510(k) should state that the submission id part of the Quick Review Program Pilot. Otherwise, it will be received as a traditional 510(k).

What are the Review Timeline and Fees?

For 510(k)s submitted as part of the Quick Review Program, the refuse to accept (RTA) review is not conducted and the final decision for the 510(k)s is made by the FDA within 60 days of receipt.

510(k)s submitted as part of the Quick Review Program pilot are subject to the same user fees than a traditional 510(k). For the current User Fee amounts, please see MDUFA User Fees.

The list of eligible devices with their product codes :

If you have questions about your eligibility for this Quick Review Program Pilot, or need help in the preparation and submission of the 510(k) using the eSubmitter, please contact Global Regulatory Partners at info@globalregulatorypartners.com and we will get back to within 24 hours.