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# FDA Launches Quik Review 510(k) Pilot
- URL: https://www.fdaweb.com/fda-launches-quik-review-510-k-pilot/
- Published: 2018-09-05T12:00:00.000Z
- Updated: 2026-09-15T00:29:51.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142276

FDA says it is launching a Quality in 510(k) (Quik) Review Program pilot for some moderate-risk medical devices. The program will allow sponsors of certain moderate risk medical devices to use the FDA eSubmitter software to structure their 510(k) applications for submission to the agency. An agency notice says FDA expects the new format to help reduce the maximum time to make a review decision for most products in the Quik Review pilot from 90 days to 60 days. The format does not change any statutory or data requirements for device sponsors to demonstrate their devices are substantially equivalent to a predicate device.

Commenting on the pilot, FDA commissioner **Scott Gottlieb** [says](https://www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm619488.htm?ref=fdaweb.com) it “will improve our overall productivity, enabling, the agency’s review staff to put more of our time and resources into evaluating applications for devices that pose the highest potential risk to patients. Simplifying the process to submit applications is part of FDA’s ongoing effort to ensure that we’re giving patients more efficient access to safe, effective, and high-quality medical devices.”