FDA Exempts Low-Risk, Some Class II Devices From 510(K) Requirements
This article was originally published in The Gray Sheet
Executive Summary
FDA finalized plans to not require 510(k) submissions for about 120 product codes. The agency added 16 codes to the list from its August 2014 proposal, but removed two other codes in a final guidance posted June 30. The devices fall in class I, class II or are unclassified.