Quik Program Explained in Webinar

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 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.