FSMA 204 · 21 CFR Part 1 Subpart S · FTL · Not enforced before Jul 2028
FSMA 204 software with KDEs captured at the CTE — not reconstructed after.
The FDA Food Traceability Final Rule (21 CFR Part 1 Subpart S) requires Key Data Elements at every Critical Tracking Event for foods on the Food Traceability List. FDA says it will not enforce the rule before July 20, 2028.
KDE Capture at Every CTE
One-Up / One-Back Linkage
Sortable Spreadsheet Export
Traceability Plan (§1.1315)
Full product detailCommon problems, what's included, why teams choose it, and where commercial meets regulated.
You're shopping for FSMA 204 software because the Food Traceability Rule is coming and traceability lives on paper.
KDEs aren't captured at the CTE — they're reconstructed from ASNs and receiving logs
One-up / one-back linkage lives in spreadsheets across three sites
A 24-hour FDA data request would take your team a week
The Traceability Plan is a Word document nobody has opened since it was written
Transformation events (mixing, packing, repacking) break the lot lineage
GFSI mock recalls take days — real recalls would take longer
Everything the Food Traceability Rule expects — live.
KDE Capture at Every CTE
Growing, receiving, creating, transformation and shipping events all record the FDA-specified Key Data Elements at the moment they happen — dock-door scan, line transaction, ship confirm.
One-Up / One-Back Linkage
Every lot knows its immediate previous source and immediate subsequent recipient. Full pedigree is a query, not a spreadsheet reconstruction.
Sortable Spreadsheet Export
FDA's requested format produced — filtered by FTL commodity, date range, lot code or location. Well inside the 24-hour statutory maximum.
Traceability Plan (§1.1315)
The rule requires a written Traceability Plan describing procedures, records, farm map (where relevant) and an assigned point of contact. V5 hosts it, versions it, and links it to the live evidence.
Recall & Mock-Recall Drill
Lot-level lookup with customer, quantity, ship-date, on-hand and hold-status is a single query. Sub-hour drills meet SQF, BRCGS and FSSC time limits.
GS1 & Label-Native
GS1-128, GTIN + lot + date scan at receiving and shipping. Traceability lot code carried through transformation. No reliance on OCR or manual re-key.
What FSMA 204 readiness actually looks like.
- FSMA 204 KDEs captured the day the rule is enforced — not the day of the audit
- 24-hour FDA data request answered
- Same evidence base serves SQF Edition 9, BRCGS Issue 9 and FSSC 22000 v6
- Sub-hour mock-recall drill on lot-level pedigree
The rules and schemes your customers audit you against.
FSMA 204 (21 CFR Part 1 Subpart S)
Food Traceability Rule — KDEs at CTEs for FTL foods, one-up / one-back linkage, sortable spreadsheet within 24 hours of FDA request, written Traceability Plan. FDA has proposed a July 20, 2028 compliance date and says it will not enforce the rule before that date.
HACCP / HARPC (21 CFR Part 117)
Preventive Controls for Human Food — hazard analysis, preventive controls, monitoring, corrective actions, verification, supply-chain program, recall plan.
SQF Edition 9
System elements and food safety fundamentals evidenced live. Unannounced re-cert evidence kept current.
BRCGS Food Safety Issue 9
Fundamental requirements, HACCP, food safety and quality management, product control, process control — all evidenced.
FSSC 22000 v6
ISO 22000 + ISO/TS 22002-1 PRPs + FSSC additional requirements. Food safety culture and food defence programs modeled.
FSMA 204 software, answered.
What is FSMA 204?
FSMA 204 is shorthand for the FDA Food Traceability Final Rule under section 204 of the Food Safety Modernization Act, codified as 21 CFR Part 1 Subpart S. It requires enhanced recordkeeping — Key Data Elements captured at Critical Tracking Events — for foods on the Food Traceability List.
When does the rule take effect?
The original compliance date was January 20, 2026. FDA has proposed extending it by 30 months to July 20, 2028, and the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 directed FDA not to enforce the rule before that date; FDA says it intends to comply. The proposed extension is not a final rule.
What foods are covered?
The FDA's Food Traceability List (FTL) covers cheeses, shell eggs, nut butters, cucumbers, herbs, leafy greens, melons, peppers, sprouts, tomatoes, tropical tree fruits, various fish and molluscan shellfish, and ready-to-eat deli salads. If any FTL food is in your supply chain, the rule applies.
What are KDEs and CTEs?
Critical Tracking Events are growing, receiving, creating, transformation, and shipping. Key Data Elements are the required data points at each CTE — for shipping, that's the traceability lot code, quantity, unit of measure, shipper, receiver, ship-from and ship-to, ship date, and reference record.
Do we still need HACCP?
Yes. FSMA 204 sits on top of Part 117 Preventive Controls (HARPC). V5 runs both on one platform — HACCP plan management, monitoring at the CCP, deviation and verification workflow, plus FSMA 204 traceability.
Capabilities vary by plan and setup. Confirm specifics with our team before relying on them.