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

Webinar on FDA’s New eMDR Requirements

Posted on Jul 15, 2015 2:04:05 PM

Seminar - Online
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.
Organization: Compliance Trainings (
Monday, July 13, 2015 (13:0014:00)
Mississauga, Ontario 44813, Canada
Contact: Compliance Trainings (
Phone: 4169154458
If you'd like to ask a question or post a comment about this talk please do so below.
This seminar posting is brought to you by Biotechnology Calendar, Inc. providing access to research information and research tools for nearly 20 years. Visit our Science Market Update Blog for current science funding and market information or see our schedule of upcoming science research laboratory product shows.

Tags: Medical Device Technology, July, Webinar, 2015, Seminar

This meeting information is brought to you by Biotechnology Calendar, Inc

We connect researchers with the tools they need to succeed. 

Get 2020 Schedule

sell more lab supplies