CSMS # 63566274 - U.S. Food and Drug Administration (FDA) Supplemental Guide DRAFT Version 2.5.12 - Update

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CSMS # 63566274 - U.S. Food and Drug Administration (FDA) Supplemental Guide DRAFT Version 2.5.12 - Update

An updated draft version of the U.S. Food and Drug Administration (FDA) Supplemental Guide (SG) (Draft Version 2.5.12 – updated 12/26/24) has been posted in the Draft Chapters: Future Capabilities section of CBP.gov.

The following updates were made for Non-PN Food or PN Requirements Previously Met, Section 10.2, deployed in CERT on December 16, 2024:

Intended Use Code (IUC) was changed from optional to conditional.
Note 3 no longer indicates IUC is optional for food contact substances.

Review the Change Log in the draft document for all changes included in SG Draft Version 2.5.12. The changes associated with SG Draft Version will be deployed in PRODUCTION no earlier than February 1, 2025.

For questions about these changes, contact FDA ACE Support ACE_Support@fda.hhs.gov.

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