FSMA 204
Structure the Critical Tracking Events and Key Data Elements behind FSMA 204.
The FDA Food Traceability Rule requires covered persons handling foods on the Food Traceability List to maintain specified Key Data Elements for relevant Critical Tracking Events and provide information to FDA within the required timeframe.
The FDA Food Traceability Rule requires covered persons handling foods on the Food Traceability List to maintain specified Key Data Elements for relevant Critical Tracking Events and provide information to FDA within the required timeframe.
Current timing
The original compliance date was 20 January 2026. FDA states that it intends not to enforce the rule before 20 July 2028 following Congressional direction. Monitor the FDA page for the current legal and enforcement position.
What an implementation needs
Applicability and role assessment.
Food Traceability List scope.
Traceability lot code strategy.
Relevant CTEs and KDEs.
Location, party and product identifiers.
Transformation and shipment relationships.
Traceability plan and record ownership.
Ability to retrieve and explain connected records.
How TRAZEIT supports the workflow
Configure required events and fields, connect records across participants, validate completeness and retrieve the history for a selected traceability lot code. The configuration must reflect the organisation’s role and qualified regulatory interpretation.
Frequently asked questions
Are CTEs and KDEs unique to FSMA 204?
They are also core traceability concepts used by GS1. The exact regulatory requirements under FSMA 204 must be mapped to the rule.
Does software make a business compliant?
No. Compliance depends on scope, process, data, governance, partner participation and ongoing operation.
TAKE THE NEXT STEP
Map your covered flow and traceability lot code.
Start with one representative product flow and a focused conversation.