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Electronic Medical Device Reporting: Questions and Answers on Electronic Submission of Postmarket Reports

This guidance provides answers to questions related to FDA's final rule requiring device manufacturers and importers to submit mandatory reports of individual medical device adverse events (MDRs) electronically. While electronic reporting is available to user facilities, they are permitted to continue submitting written reports. The guidance explains how to prepare and send electronic postmarket medical device reports to CDRH.

  1. Set up Web Trader Account with FDA’s Electronic Submissions Gateway (ESG)
  2. Submit Letter of Non-Repudiation to FDA
  3. Obtain personal digital certificate
  4. Choose and implement appropriate submission method (eSubmitter or HL7 ICSR)
  5. Conduct test submissions before going live
  6. Establish procedures for:
    • Maintaining copies of submissions and acknowledgments
    • Handling error messages and resubmissions
    • Managing system outages
    • Submitting supplemental/follow-up reports
  7. Train staff on new electronic submission procedures
  8. Monitor FDA websites for updates on software changes and system maintenance
  9. Establish backup reporting method for system outages

Key Considerations

Software

  • Two options available for creating eMDR submissions:
    • FDA eSubmitter software (free downloadable application)
    • Health Level Seven (HL7) Individual Case Safety Reporting
  • Systems should be able to save/print reports and encode attachments
  • Specific data format requirements following HL7 ICSR message format

Cybersecurity

  • Digital certificates required for authentication
  • Web Trader Account setup needed
  • Letter of Non-Repudiation required

Other considerations

  • HL7 ICSR: Health Level Seven Individual Case Safety Report Implementation Guide for FDA Medical Device Reporting

Original guidance

  • Electronic Medical Device Reporting: Questions and Answers on Electronic Submission of Postmarket Reports
  • HTML / PDF
  • Issue date: 2014-02-13
  • Last changed date: 2020-03-02
  • Status: FINAL
  • Official FDA topics: Medical Devices, Adverse Event Reporting System (FAERS), Adverse Event Reporting
  • ReguVirta summary file ID: 551cdc57cc51d325bb48511ab4b95244
This post is licensed under CC BY 4.0 by the author.