FDA Releases Final eMDR Rule and Deadline for Compliance


The Food and Drug Administration (FDA) announced and is promulgating today the Final Rule on Electronic Medical Device Reporting (eMDR). Originally proposed in 2009, the rule is now final and a deadline for compliance has been identified. The rule impacts device manufacturers and importers and mandates electronic submission of individual medical device adverse event reports. User facilities may continue to submit only written reports.

As of August 14, 2015, postmarket medical device adverse event reports by manufacturers and importers must be submitted only electronically to the FDA’s Center for Devices and Radiological Health via the Electronic Submissions Gateway (ESG). The ESG is used for all forms of electronic filing to the FDA; information specific to medical device submissions is available here. Guidance about the eMDR is available here.

We recommend you review your current system for submitting reports, and if you are not already utilizing the ESG for all reporting, develop a plan now for integrating the electronic process into your operations.

Topics:  Compliance, FDA, Medical Devices

Published In: Health Updates, Science, Computers & Technology Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Mintz Levin - Health Law & Policy Matters | Attorney Advertising

Don't miss a thing! Build a custom news brief:

Read fresh new writing on compliance, cybersecurity, Dodd-Frank, whistleblowers, social media, hiring & firing, patent reform, the NLRB, Obamacare, the SEC…

…or whatever matters the most to you. Follow authors, firms, and topics on JD Supra.

Create your news brief now - it's free and easy »