# 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.

[View original listing](https://www.federalregister.gov/documents/2026/10/16/2026-21195/electronic-common-technical-document-data-standards-center-for-drug-evaluation-and-research-and)