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CTE and KDE Mapping Worksheet

This worksheet maps each applicable CTE to the KDEs required for that event. It is illustrative, not a universal or legally complete KDE specification.

Start with the complete guideReadiness checklist
Illustration of food scope, tracking events, linked data, and record retrieval
Regulatory status: FDA describes the original date as 20 January 2026, a proposed extension to 20 July 2028, and a congressional directive not to enforce before that date. FDA says it intends to comply. Read the dated update.
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Phase 4 — Tools & TrainingTopic: FSMA 204 CTE KDE mapping worksheetReviewed: 30 October 2026
In brief: This worksheet maps each applicable CTE to the KDEs required for that event. It is illustrative, not a universal or legally complete KDE specification.

What this guide covers

List CTEs the entity performs and identify the applicable provision and KDEs. Record the exact source for every field.

Practical implementation

For each KDE, record the source document/system, owner, validation rule, exchange method, and gap status. Check that records remain linked to the correct lot and event.

Limitations and verification

Do not copy a generic field list across every event. Mark unresolved interpretations for specialist review.

Download the editable worksheet

Download CSV worksheet

How to complete the event-to-data map

Complete one row for each distinct food/activity combination rather than one row per facility. Record the physical trigger, the event definition reviewed, the applicable product scope, the KDE list and the record that captures each value. Add a source citation or CFR section for the legal requirement and mark internal control fields separately. This prevents the worksheet from becoming an undifferentiated list of every field anyone might want.

For each KDE, identify the data owner, source system, format, validation rule, downstream recipient and exception route. If a value comes from a supplier, record how the company verifies it and what happens when it is missing. Test one completed row against an actual transaction and keep the test evidence with the worksheet.

This worksheet is an internal planning aid, not an FDA-prescribed form and not a legal scope determination. Confirm the final field set against the current regulation and FDA material.

How to verify this information

Official and supporting sources

Verify important regulatory claims against primary sources. Draft guidance is non-binding.

Educational information only. The regulation and current official guidance control. This page is not legal advice, FDA approval, or a guarantee of compliance.