Manufacturer omission of MDR user facility data is common deficiency, FDA says.
This article was originally published in The Gray Sheet
Executive Summary
MANUFACTURER MDR REPORTS OMITTING USER FACILITY DATA is a common deficiency in medical device adverse event reports submitted to FDA, according to agency staffers. Many device companies are neglecting to complete Section F of the 3500A MDR form when it is left blank by user facilities or distributors, FDA says.