Opportunity
Federal Register #2026-21195
FDA Announces High-Severity eCTD Submission Validation Checks
Buyer
Department of Health and Human Services / Food and Drug Administration
Posted
October 16, 2026
Identifier
2026-21195
The FDA announced high-severity validation checks for electronic regulatory submissions using eCTD versions 3.2.2 and 4.0. - Government buyer: U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA), through the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). - Validation checks: Submissions using eCTD version 3.2.2 will be checked against criteria 2024 and 2025. Submissions using eCTD version 4.0 will be checked against eCTD4-084, eCTD4-085, and US-eCTD4-561 through US-eCTD4-564. - Requirement: FDA will reject electronic submissions that fail the specified high-severity checks, as described in the applicable eCTD validation criteria specifications. - Procurement status: This is an informational notice, not a request for products or services. No OEMs, vendors, product quantities, or service line items are identified.
Description
The FDA announces that it will begin rejecting electronic submissions that fail new high-severity validation checks for Electronic Common Technical Document (eCTD) versions 3.2.2 and 4.0 on January 16, 2027. The specified eCTD v3.2.2 validations are 2024 and 2025; the specified v4.0 validations are eCTD4-084, eCTD4-085, and US-eCTD4-561 through US-eCTD4-564. These validations are described in the respective eCTD validation criteria specifications. The notice also states that electronic or written comments may be submitted at any time.