On October 10, 2018, FDA will host a webinar to share information and answer questions about the Quality in 510(k) (“Quik”) Review Program pilot. More information about the webinar is available here. On September 6, FDA launched the “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 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 a Refuse to Accept (RTA) review. Instead, submissions will undergo an interactive review, and FDA intends to make a final decision within 60 days without placing the file on hold. 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.