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.
What You Need to Know? 👇
What is the deadline for mandatory electronic MDR submissions to FDA?
The eMDR Final Rule requirements became effective on August 14, 2015. Manufacturers and importers must submit medical device reports electronically, while user facilities may continue submitting paper reports but can opt for electronic submission.
How do I know if my electronic MDR submission was successfully processed by FDA?
FDA’s system sends three automatic acknowledgments: Receipt confirmation (ESG received), CDRH received confirmation, and database loading status. All three should arrive within 24 hours if no errors occur during processing.
What are the two main options for creating electronic MDR submissions?
You can use FDA eSubmitter software (free downloadable application for single reports) or Health Level Seven (HL7) Individual Case Safety Reporting (allows batch submissions and system integration for multiple reports).
What should I do if my electronic MDR fails validation according to Acknowledgment 3?
Correct the specific errors described in Acknowledgment 3 and resubmit only the failed reports. Common errors include missing required fields, incorrect formats, invalid report numbers, or character limit violations.
How do I submit follow-up or supplemental reports for previously filed MDRs?
Use the same electronic submission methods as initial reports. Include the original report number, specify it’s a follow-up, and only update changed information. Electronic supplements are required even for initially paper-filed MDRs.
What happens if system outages prevent timely electronic MDR submission?
Document attempted filing in Block H10 and submit when systems are operational. For extended outages affecting your own systems, contact eMDR@fda.hhs.gov for alternative submission instructions and timeline guidance.
What You Need to Do 👇
Recommended Actions
- Set up Web Trader Account with FDA’s Electronic Submissions Gateway (ESG)
- Submit Letter of Non-Repudiation to FDA
- Obtain personal digital certificate
- Choose and implement appropriate submission method (eSubmitter or HL7 ICSR)
- Conduct test submissions before going live
- Establish procedures for:
- Maintaining copies of submissions and acknowledgments
- Handling error messages and resubmissions
- Managing system outages
- Submitting supplemental/follow-up reports
- Train staff on new electronic submission procedures
- Monitor FDA websites for updates on software changes and system maintenance
- 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
- Three electronic acknowledgments will be sent to confirm successful submission
- Records retention requirements for eMDRs and acknowledgments
- Process defined for supplemental and follow-up reports
- Procedures for handling system outages
- Specific requirements for handling missing information using null values
- Time zone considerations for submission deadlines
Relevant Guidances 🔗
- Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
- Electronic Records and Electronic Signatures - Scope and Application
- Voluntary Malfunction Summary Reporting Program for Medical Devices
Related references and norms 📂
- 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 ID: 551cdc57cc51d325bb48511ab4b95244