Primary source: Food and Drug Administration (FDA)
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.
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.
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.
Regulatory Intelligence Lead
Review before 2026-06-29.
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.
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.
Submitters must transition to using GENC 3-letter country codes in submissions.
eMDR will no longer accept ISO 3166-1 alpha-2 country codes.
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.
Published from the Firecrawl policy change extraction pipeline.
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