Regulatory Focus™ > News Articles > FDA Finalizes Electronic Medical Device Reporting Rule

Posted 14 February 2014 | By Alexander Gaffney, RAC

FDA Finalizes Electronic Medical Device Reporting Rule


A final rule promulgated by the US Food and Drug Administration (FDA) will require medical device manufacturers and importers to submit adverse event reports to the agency through a specific electronic format.

While FDA has long required manufacturers to report adverse events to it under 21 CFR 803, the medical device reporting (MDR) regulation, those reports have been submitted in paper form through Form FDA-3500A.

But as with many forms submitted to FDA, the agency is moving toward an electronic submission standard, arguing that digital submission is faster, cheaper, more accurate and allows for better analysis and reporting.

So in 2009, FDA proposed a rule that would require manufacturers, facilities and importers to submit MDRs to it electronically. However, after a review by FDA, it determined that the cost of implementing electronic reporting provisions would be cost prohibitive to user facilities, and thus dropped them from the required reporters under the rule. They may continue to use either paper reporting or electronic reporting, if they so choose, FDA said. Unlike manufacturers and importers, adverse event reporting is optional for facilities. Edit: Facilities are subject to reduced--not optional--reporting requirements. We regret the error. 

Aside from that change, though, little else is different in the 2014 final version of the 2009 rule. Industry will still have two options to report MDRs to FDA, one for single reports using the eSubmitter tool, and the other for batch reports using the Health Level 7 Individual Case Safety Reporting (ICSR) tool.

The rest of the final rule goes into the nuts and bolts of actually submitting an MDR to FDA, including how to determine if FDA received and processed a company's MDR, exemptions from the electronic MDR rule, recordkeeping requirements, and what to do in the case of a system outage (answer: document submission attempts).

Also released with the rule is a question and answer guidance document, Questions and Answers about eMDR - Electronic Medical Device Reporting, which provides a step-by-step walkthrough of preparing and submitting an MDR application to FDA.

The rule goes into effect on 14 August 2015.


edical-device-reporting-electronic-submission-requirements">Final Rule

Guidance (FR)


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