Voluntary Summary Quarterly MDR Program for Manufacturers Goes into Effect; FDA Notice Sets Scope, Conditions
August 21, 2018 at 01:35 PM EST
The FDA Aug. 17 finalized a voluntary program allowing medical device manufacturers to submit some reports of product malfunctions in summary form on a quarterly basis rather than individually.
Streamlining the submission of some medical device reports (MDRs) through the Voluntary Malfunction Summary Reporting Program for Manufacturers will allow the agency “to more efficient... Read More
