Quality in 510(k) "Quik" Review Program Pilot

Quality in 510(k) "Quik" Review Program Pilot

Today the U.S. Food and Drug Administration (FDA) is launching the Quality in 510(k) (“Quik”) Review Program pilot. The goal of this pilot is to simplify how manufacturers of certain moderate risk medical devices complete a premarket notification (510(k)) submission, and to evaluate whether use of the FDA’s free eSubmitter software will result in well-organized submissions that can be reviewed more efficiently.  Knowing what documentation to include in a 510(k) submission can be challenging for device manufacturers. Before this pilot, there was no standard form to submit a 510(k), and manufacturers were required to submit both a paper and an electronic copy of their application. The Quik Review Program pilot allows manufacturers to use the FDA’s free downloadable eSubmitter software to enter information into fields required in all 510(k) applications, and save the completed file to a CD, DVD, or USB drive. This ensures complete applications in a structured format. Device manufacturers will submit an electronic version of their 510(k) to FDA’s Document Control Center, rather than needing to submit both a hard copy and an electronic copy. In addition, 510(k) submissions eligible for the Quik Review Program pilot will not be subject to aRefuse to Accept (RTA) review. Instead, submissions will undergo an interactive review, and the FDA intends to make a final decision within 60 days without placing the file on hold. The FDA believes that because the eligible products are well-understood, and the submissions are well-organized, the Quik Review Program pilot will improve efficiency in review. The Quik Review Program pilot does not change any requirements for the determination of substantial equivalence.  To find out if your 510(k) submission is eligible for the Quik Review Program pilot, review the eligible product codes list on the Quik Review Program Pilot webpage. On October 10, 2018, the FDA will host a webinar to share information and answer questions about the pilot. More information about the webinar is available at http://www.fda.gov/CDRHwebinar. If you have general questions about this pilot, or are interested in participating, please visit our websiteat or contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100 or dice@fda.hhs.gov. Food and Drug Administration Center for Devices and Radiological Health