FDA Requires Electronic Submission Of Adverse Event Reports By August 2015-thegraysheet: Beginning 18 months from now, medical device manufacturers will be required to submit their adverse event reports to FDA electronically, instead of on paper. The new requirement applies to all device manufacturers and importers, regardless of their size. It goes into effect on Aug. 14, 2015. The details are spelled out in a final rule (PDF) issued by the agency Feb. 13.
