FDA TO REPROPOSE ANNUAL MANUFACTURER CERTIFICATION, U.S. DESIGNATED AGENT PROVISIONS OF MDR REG; REMAINDER OF RULE WILL GO INTO EFFECT ON SCHEDULE
This article was originally published in The Gray Sheet
Executive Summary
FDA will repropose the annual manufacturer certification and U.S. designated agent provisions of its December 1995 final medical device reporting rule in order to allow for further consideration of manufacturer concerns. The reproposal will occur in the next few months and will be followed by a 60-day comment period.