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# Quik Program Explained in Webinar
- URL: https://www.fdaweb.com/quik-program-explained-in-webinar/
- Published: 2018-10-18T12:00:00.000Z
- Updated: 2026-09-15T00:39:13.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142614

A 10/10 CDRH Webinar explained the Quality in 510(k) (Quik) Review Program that provides an alternate method to submit a 510(k) to FDA using the eSubmitter software to format the submission. CDRH biomedical engineer **Angela DeMarco** [said](https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm619574.htm?ref=fdaweb.com) the purpose of the Quik pilot program is to simplify how manufacturers complete a 510(k) submission for moderate-risk medical devices and to evaluate whether use of eSubmitter will result in well-organized submissions that can be reviewed more efficiently.

Outside the scope of the pilot are special 510(k)s, in vitro diagnostics, and biologic products. To be eligible for the pilot, a 510(k) must meet all of these criteria: **(1)** the primary product code must be on the pre-identified list of product codes; **(2)** the 510(k) must be constructed using the Non-In Vitro Diagnostic Device-510(k) eSubmitter template; **(3)** the product is not a combination product; and **(4)** the lead Center must be CDRH.