PV Bulletin

eMDR System Enhancements - Production Deployment

The FDA is implementing enhancements to the eMDR system, introducing stricter validation rules and transitioning to GENC codes.

Primary source: Food and Drug Administration (FDA)

PV Impact Brief

Urgency: HighConfidence: high

What changed

Introduction of stricter technical validation rules for electronic submissions; reports lacking fields B5 (event description) and H1 (reportable event type) in Form 3500A will be rejected starting July 20, 2026. ISO 3166-1 alpha-2 country codes will no longer be accepted.

Why it matters

This change ensures accurate and compliant reporting in line with international standards, impacting all users of the eMDR system and potentially affecting the usability of electronic safety reporting systems.

Action needed

Update electronic safety reporting systems and pharmacovigilance databases to implement new rules to ensure all submissions use GENC 3-letter country codes and include the required fields as of July 20, 2026.

Relevant for
Regulatory Intelligence LeadQPPV
Processes impacted
ICSRCountry Compliance
Owner

Regulatory Intelligence Lead

Review cadence

Review before 2026-06-29.

Policy change details

Document type
Notice
Policy status
effective
Publication date
2026-07-27
Effective date
2026-07-27
Policy change
FDA announced a production deployment for the Electronic Medical Device Reporting (eMDR) system effective July 27, 2026. This enhancement involves a transition in data validation rules where the system will no longer accept ISO 3166-1 alpha-2 country codes. The eMDR system will begin rejecting reports that use these codes as part of the AEMS consolidation process.

Key changes

The primary technical change is the rejection of ISO 3166-1 alpha-2 country codes in electronic submissions. Sponsors and manufacturers must update their reporting software or data entry processes to ensure compliance with the new system requirements to avoid rejection of reports.

Affected workflows

ICSRCountry Compliance

PV impact

Safety and vigilance teams responsible for medical device reporting (eMDR) must immediately update their data fields and submission systems to remove alpha-2 country codes. Failure to do so will result in technical rejections of safety reports by the FDA. This requires urgent coordination with IT and system vendors.

View regulator source

Source document details

Exact policy details

Scheduled Outage for eMDR Deployment
July 22, 2026, 7:00 PM EST to July 27, 2026, 9:00 AM EST
Applies to: All eMDR submitters
There will be a scheduled outage from July 22, 2026, 7:00 PM EST to July 27, 2026, 9:00 AM EST for this deployment. · p. 1 · High · Source
MDR Receive Date for Submissions During Outage
Timestamp in Ack1 is considered the MDR receive date for regulatory purposes.
Applies to: All submissions during scheduled outages
Please note that the timestamp in Ack1 is considered the MDR receive date for regulatory purposes. · p. 1 · High · Source
Impact Statement for Submissions Affected by Scheduled Downtime
Include statement in Block H11: 'This report was impacted by eMDR scheduled maintenance occurring July 22-27, 2026.'
Applies to: All submitters with reports affected by scheduled downtime
Submitters with reports impacted by this scheduled downtime should include the following statement in Block H11 of the FDA 3500A form... · p. 1 · High · Source
Submission Format Requirements
No longer accepting ISO 3166-1 alpha-2 country codes.
Applies to: AS2/API submitters
With the AEMS consolidation, eMDR will begin rejecting ISO 3166-1 alpha-2 country codes... · p. 1 · High · Source

Workflow rule impacts

Country ComplianceCompliance Teams

Submitters must transition to using GENC 3-letter country codes in submissions.

eMDR will no longer accept ISO 3166-1 alpha-2 country codes.

eMDR will begin rejecting ISO 3166-1 alpha-2 country codes, which are not compliant with the XML specification. · p. 1 · High · Source

Extracted documents

Unable to extract linked source document: https://www.hhs.gov/vulnerability-disclosure-policy/index.html

Evidence and confidence

Confidence: highSource updated: Jun 29, 2026

Full briefing

Practical implication

Update electronic safety reporting systems and pharmacovigilance databases to implement new rules to ensure all submissions use GENC 3-letter country codes and include the required fields as of July 20, 2026.

The FDA’s eMDR system will undergo significant enhancements including the rejection of reports missing critical fields and the transition from ISO 3166-1 alpha-2 country codes to GENC alpha-3 codes. Compliance updates are required by July 20, 2026, to avoid report rejections.

What changed: Introduction of stricter technical validation rules for electronic submissions; reports lacking fields B5 (event description) and H1 (reportable event type) in Form 3500A will be rejected starting July 20, 2026. ISO 3166-1 alpha-2 country codes will no longer be accepted.

Why it matters: This change ensures accurate and compliant reporting in line with international standards, impacting all users of the eMDR system and potentially affecting the usability of electronic safety reporting systems.

Practical implication: Update electronic safety reporting systems and pharmacovigilance databases to implement new rules to ensure all submissions use GENC 3-letter country codes and include the required fields as of July 20, 2026.

View original source

Published from the Firecrawl policy change extraction pipeline.

#Safety Signals#Reporting Requirement#policy-change#firecrawl-policy-agent#Effective#Food and Drug Administration (FDA)#Process Change

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