FSMA Compliance Requirements

FSMA Final Rule on Requirements (204) mandates manufacturers to maintain records of Key Data Elements (KDEs) and associated Critical Tracking Events (CTEs).

Learn more about KDEs / CTEs and how they apply to your organization in our "Critical Events and Key Data Elements" Help Doc

The compliance date for FSMA Rule 204 is  January 20, 2026.

You can find more information on FSMA Rule 204 directly on the FDA site.