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  7. eMDR System Enhancements
  1. eMDR – Electronic Medical Device Reporting

eMDR System Enhancements

The FDA recognizes the importance of providing early notice and predictability about potential eMDR system changes, especially for high-volume submitters. Therefore, the FDA is implementing enhancements to the eMDR System on a regular schedule. 

Firms that utilize third party applications to create eMDR submission files should use the information on this page to plan system updates to align with these eMDR system enhancements as soon as possible. Low-volume firms should note that the FDA eSubmitter client is updated concurrently with the eMDR system.

Through this schedule, the FDA expects to take the next steps for every cycle of new enhancements:  

  1. Announce upcoming enhancements in June,  
  2. Release the Implementation Package in August,  
  3. Deploy enhancements to pre-production (ESG NextGen Test) in September, and  
  4. Deploy high-impact enhancements to production 7 months after the Implementation Package is released, typically in March of the following year. 

While the FDA expects to follow this schedule for future enhancements, it is possible that emergency fixes may need to be implemented outside the schedule. Additionally, if major system changes are necessary in the future, additional time will be provided between release of the implementation package and production deployment.

We will provide regular communications on this page at each point in the process. This information will also be emailed to the CDRH Industry's email list.

Please contact the eMDR helpdesk at MDRTHelpdesk@fda.hhs.gov for any questions or concerns about specifications and enhancements. Industry may use eMDR Test for testing system updates at any time.

Upcoming Enhancements to eMDR

ChangeCommentsSchedule
eMDR consolidation with Adverse Event Monitoring System (AEMS)

To provide additional information on the AEMS announcement for AS2/API submitters (eSubmitter users will not be affected):

  • The electronic MDR submission format and destination address will not change
  • There will be minor changes in Ack3 error messages, but parsing will not be affected
  • Please review the eMDR Implementation Package and verify that all systems comply with the August 2024 XML specification

May 11, 2026: Test deployment to eMDR.

May 31, 2026: Production deployment to eMDR.

No longer accepting ISO 3166-1 alpha-2 country codes    With the AEMS consolidation, eMDR will begin rejecting ISO 3166-1 alpha-2 country codes, which are not compliant with the XML specification. AS2/API submitters should use Geopolitical Entities, Names and Codes (GENC) 3-letter country codes in their submissions. While FIPS 10-4 codes are currently accepted, they were withdrawn in 2008 and are no longer recommended for use. These requirements have been documented in the eMDR Implementation Package since 2020.

May 11, 2026: Test deployment to eMDR.

May 31, 2026: Production deployment to eMDR

International Medical Device Regulators Forum (IMDRF) 2025 maintenance updates    The Adverse Event codes accepted in sections F10 and H6 of the Form 3500A were updated to harmonize with maintenance updates from IMDRF in Fall 2025. A summary of the changes and the new hierarchy file have been released at Coding Resources for Medical Device Reports.

September 26, 2025: Test deployment to eMDR.

October 6, 2025: Users (including eSubmitter) can begin using the new codes. AS2/API users to implement the new codes by March 31, 2027.

International Medical Device Regulators Forum (IMDRF) 2026 maintenance updatesThe Adverse Event codes accepted in sections F10 and H6 of the Form 3500A will be updated to harmonize with maintenance updates from IMDRF. A summary of the changes and the new hierarchy file will be released in August 2026 at Coding Resources for Medical Device Reports.

September 2026: Test deployment to eMDR.

October 2026: Users (including eSubmitter) can begin using the new codes. AS2/API users to implement the new codes by March 31, 2027.

List of Historical eMDR Changes

ChangeComments
2024 eMDR Enhancements
  • No longer accepting:
    • Patient Weight without patient weight unit
    • Initial manufacturer or importer reports without all Adverse Event codes in section H6 (for manufacturers) or F10 (for importers)
  • International Medical Device Regulators Forum (IMDRF) 2024 maintenance updates
2023 eMDR Enhancements
  • No longer accepting multiple G4 PMA, 510(k), or device BLA numbers
  • Update electronic form labels to match Form FDA 3500A 
  • Add the following fields:
    • A3b Patient Sex field
    • D4 Additional Unique Device Identification (UDI) field 
    • Organization Name field under F3 contact information
    • H10 Related Report Numbers field
  • Remove Form Code field
  • Increase H9 FDA Action Code length to 50 characters
  • Accept manufacturer and importer MDRs with 7-digit sequence numbers
  • International Medical Device Regulators Forum (IMDRF) 2023 maintenance updates
2022 eMDR Enhancements
  • No longer accepting:
    • Patient Age without patient age unit
    • Blank Product Code
    • Implant date greater than explant date
  • Reports that do not include Adverse Event Problem codes
  • Reports that do not provide a contact email address
  • International Medical Device Regulators Forum (IMDRF) 2022 maintenance updates
2021 eMDR Enhancements
  • Adverse Event codes accepted in sections F10 and H6 of the 3500A form were updated to harmonize with maintenance updates from IMDRF.
2020 eMDR Enhancements
  • Exemption Number field added
  • Updates to align with the new FDA Form 3500A 
    • included new options in A3 Patient Sex
    • new fields for C6 Generic and Biosimilar
    • new field for D8 Device Serviced By a Third Party
    • new options for E3 Reporter Occupation
    • new field for G4 PreANDA
    • new field for G5 Combination Product
    • new fields in H1 for Summary Report, for example, Voluntary Malfunction Summary Reports (VMSR) and Number of Events 
    • new fields for H6 Health Effect Impact Code and Medical Device Component Code
  • Adverse Event codes accepted in F10 and H6 were updated to complete harmonization with the IMDRF Adverse Event Reporting Terminologies.
  • IMDRF Adverse Event codes accepted in F10 and H6 were updated to complete harmonization with the IMDRF Adverse Event Reporting Terminologies.
  • Country code formats clarification
    • Two-letter codes are interpreted as FIPS 10-4. 
    • Three-letter codes are interpreted as GENC. 
2018 eMDR Enhancements
  • Enforcement of Supplement Numbering Requirements
  • FDA Adverse Event codes accepted in F10 and H6 were updated to harmonize with the IMDRF Adverse Event Reporting Terminologies, Annexes A-D
2017 eMDR Enhancements
  • Environment and Submission Type elements added to Ack3
  • HL7 ICSR R2 XML format update
  • Combination product fields added
  • FDA Form 3500A version 9/30/2018 updates
  • D4 UDI guidance update
  • Reports without B5 and H1 will be rejected

Other Resources

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