CSMS #63566274Monday, December 30, 2024
PGA UpdateMedium UrgencyAction Required

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

Type: UPDATE

CSMS # 63566274 - U.S. Food and Drug Administration (FDA) Supplemental Guide DRAFT Version 2.5.12 - Update
U.S. Customs and Border Protection sent this bulletin at 12/30/2024 04:41 PM EST
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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Additional Information

Programs Affected:
ACE
PGAs Affected:
FDA