11th September 2018
The FDA has launched the Quality in 510(k) ('Quik') Review Programme 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-organised 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 Programme 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 Centre, rather than needing to submit both a hard copy and an electronic copy.
In addition, 510(k) submissions eligible for the Quik Review Programme pilot will not be subject to a Refuse 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-organised, the Quik Review Program pilot will improve efficiency in review.
The Quik Review Programme 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 Programme pilot, review the eligible product codes list on the Quik Review Programme Pilot webpage.
On 10th October, 2018, the FDA will host a webinar to share information and answer questions about the pilot. More information is available at www.fda.gov/CDRHwebinar
If you have general questions about this pilot, or are interested in participating, please visit the FDA website or contact the Division of Industry and Consumer Education (DICE) in the Centre for Devices and Radiological Health (CDRH) at +1-800-638-2041, 301-796-7100 or firstname.lastname@example.org.