FDA Final Ruling on electronic MedWatch reports: The Impact on the Industry

FDA Final Ruling on electronic MedWatch reports: The Impact on the Industry

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

Have you heard the big news? All mandatory 3500A MedWatch reports submitted by medical device manufacturers and importers must be now submitted electronically. On February 14, 2014, the FDA released its final decision on electronic Medical Device Reporting (eMDR). By August 14, 2015, all medical device manufacturers and importers will be required to submit mandatory 3500A MedWatch reports electronically to the FDA’s Center for Device and Radiological Health (CDRH). We’ve been waiting for this final decision since 2009 when the rule was proposed and opened for public comment.

But now that it’s finally here, what does it mean for the industry?

First and most importantly, this will have a beneficial impact on public health and safety issues. Electronic submissions allow the FDA to receive and process adverse event information closer to real-time. This enables them to:

  • Improve patient safety. By identifying patterns in adverse events, the FDA can capture all the appropriate codes and trend on all data elements from initial reporting through follow-up. This allows them to require labeling or prescribing changes for medical devices within a specified time frame. Quicker access to adverse event reports also helps them aggregate the data needed to produce safety alerts — making medical devices safer for all patients.
  • Eliminate manual data entry, eliminate errors, and improve data accuracy. When paper 3500A MedWatch reports are submitted, the data is rekeyed into the FDA database, incurring non-value added costs to tax payers. Mandatory eMDR submissions will not only eliminate these costs, but will also help improve data accuracy within the FDA’s Adverse Event database.

How does this work? The CDRH sends an acknowledgement file (ACK 3) to signify whether the eMDR file has been loaded into its database. When it is rejected, it will contain a reason, such as a formatting error. This highlights another benefit of electronic reporting, as the system can automatically identify these types of errors in the report, helping to get better information to CDRH more quickly.

  • Improve communication. Finally, with eMDR, critical information arrives in a format that lends itself to comprehensive data analysis and reviews. Access to this accurate and timely information, enables the FDA to make decisions and communicate suspected problems more quickly and effectively not only within the organization but also to the medical device industry, health care providers, consumers, other government Agencies, and to other countries as well.

This type of information demonstrates that the FDA is still investigating a potential issue and empowers the health care community to make more informed choices as to which devices doctors, clinics, hospitals, or patients will continue to use or prescribe. The result of this improved communication ties back into better patient safety, allowing doctors to know when they need to monitor a patient more closely based on potential safety issues that are still being investigated. Access to this type of information sooner in the treatment cycle helps the entire industry know what to be on the lookout for, rather than having a health crisis or more serious problem down the road. Better communication brings these benefits full circle, as it ultimately helps to further improve patient safety.


There is still plenty more to discuss surrounding eMDRs, compliance management, and changes to come, so stay tuned to the Pilgrim blog for more on this and other related topics.

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Adonna Blasko

Marketing Manager, Pilgrim Quality Solutions