Science Researcher Update: Spotlight on Meetings, Conferences, and Events

Manufacturers and importers must report adverse events associated with a risk to health or death. Until now, the reports were submitted in hardcopy using MedWatch form 3500A. Managing the volume adverse event reports for industry and the FDA became increasingly difficult over time. The FDA announced its development of an electronic format for submitting Medical Devices Reports. The final rule for requiring the submission of electronic MDRs was announced on February 13, 2014. That regulation goes into effect on August 14, 2015. At that time, all MDRs submitted by manufacturers and importers must be accomplished through the FDA’s Electronic Submissions Gateway (ESG). Hardcopy reports from manufacturers and importers will not be accepted. The information requirements of an adverse event for MDR purposes remain the same. The reporting deadlines of 5, 10 or 30 days technically remain the same, although in practice the deadlines are shorter. The eMDR program is intended to provide greater efficiency, accuracy and utility to the FDA and to the industry.