Appealing a 510(k) Not Substantially Equivalent (NSE) Decision

Published on January 29, 2016
Categorized as Submissions

Helping Alice through FDALand

Our client had submitted a 510(k) and received a Not Substantially Equivalent (NSE) decision from the review staff who thought the device belonged on the PMA path. The FDA maintained the device had different technological characteristics and raised different questions of safety and effectiveness. We took the matter on appeal and convinced to Agency that the device had the same technological characteristics when considering the progression of technology in the predicate family. We also were able to convince the Agency that the device raised the same questions of safety and effectiveness. We convinced the Agency that a small confirmatory clinical trial (less than 30 patients) was sufficient for clearance versus the 300-plus trial recommended by review staff.

 

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