TWELVE-MONTH MDR REG COMPLIANCE "TRANSITION" PERIOD PLANNED BY FDA; MDR ENFORCEMENT ACTIONS WILL HAVE TO BE APPROVED BY CDRH HEADQUARTERS
This article was originally published in The Gray Sheet
Executive Summary
FDA districts will not have authority to issue warning letters citing medical device reporting violations during a one-year "transition/educational" phase-in of agency enforcement of the new MDR regulations, according to an FDA policy statement.