FDA mandates electronic reporting for med device adverse events

The U.S. Food and Drug Administration this week posted a final rule in the Federal Register mandating that device manufacturers and importers submit adverse event reports for medical devices electronically.

According to FDA, the rule--which doesn't go into effect until Aug. 14, 2015--will help the agency to improve its data collection and analysis efforts. FDA says the rule is part of a greater initiative to adopt electronic technologies to boost operational quality.

"For over 20 years, FDA received postmarket MDRs in a paper format through the mail," the rule says. "This final rule to require the electronic submission to FDA of manufacturer and importer MDRs is an important step toward improving the Agency's systems for collecting and analyzing postmarket MDRs."

Benefits of the mandate, highlighted in the rule, include:

  • Reduction of time and costs associated with data transcription
  • Improving the ability of the agency to conduct efficient data analysis and reviews
  • Enhancing FDA's ability to communicate information about suspected device-related problems to providers, consumers and other government entities

FDA estimates that the mandate will reduce its annual operating costs by $1.9 million while generating industry savings of roughly $9.2 million per year. A one-time cost for updating operating procedures and establishing electronic submission capabilities is estimated to range from $38 million to $42 million. Still, the agency says, public health benefits outweigh all of those figures.

"The most important benefit of this final rule will be to the public health because the rule will enable the agency to have quicker access to the medical device adverse event reports information and thus more quickly identify and act on any medical device problems," according to the rule. "With a standardized electronic format, the majority of medical device reports will be available for analysis within a day or two after submission."

To accompany the rule, FDA published frequently asked questions and answer about its electronic medical device reporting system on its website.

In December, lawmakers sent a letter to FDA Commissioner Margaret Hamburg questioning why an October hack of the system had not been "adequately investigated."

To learn more:
- here's the final rule in the Federal Register (.pdf)
- read through the FAQs on the FDA's website