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Compliance In Focus
Posted by Jaime Wynbrandt on Fri, Mar 21, 2014

Electronic Medical Device Reporting

For over 20 years, manufacturers have submitted post-market medical device reports (MDRs)Electronic Medical Device Reporting to the FDA in a hard copy via the mail. In 2008, the FDA starting allowing reports to be submitted electronically on a voluntary basis. In August 2009, the FDA drafted a guidance for electronic submissions of MDRs. Comments were accepted on this guidance until November 2009. On February 14, 2014, the Final Rule for this guidance was published which goes into effect August 14, 2015.

The Final Rule requires MDRs to be submitted electronically. A manufacturer would need to request and obtain an exemption to continue reporting via hard copy. Reporting requirements have not changed- therefore 5-day, 10-day and 30-day reports will still need to be reported in the same manner as outlined in 21 CFR 803.

Per the FDA, benefits of electronic submission include:

  • Reducing industry's time and costs associated with transcribing data from internal data management systems to paper and mailing the paper reports to the Agency;
  • Reducing the Agency's transcription errors, time, and costs associated with receiving paper reports and transcribing data to electronic format for review and analysis;
  • Expediting the Agency's access to safety information in a format that supports efficient and comprehensive data analysis and reviews; and
  • Enhancing the Agency's ability to rapidly communicate information about suspected problems to the medical device industry, health care providers, consumers, and other government Agencies.

What are your thoughts on electronic submissions of MDRs? Have you already been submitted electronically? How will electronic submissions benefit your company?

Photo Credit: afagen

Drugs & Devices Trial Guideline

Topics: Medical Device Reporting, MDRs, 21 CFR 803, FDA

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