Free download · Deep-dive guide

2026 FSMA 204 Readiness Checklist

Eight evidence-led pillars for planning toward July 20, 2028, the date before which Congress directed FDA not to enforce the rule. FDA’s rulemaking to make it the compliance date is not yet final.

Document scope, ingredient form, and exemptions

Map your Critical Tracking Events (CTEs)

Capture the right Key Data Elements (KDEs)

Assign Traceability Lot Codes (TLCs)

Choose a requirements-led record architecture

Build the five-element plan and test retrieval

Current through July 14, 2026: the rule still identifies January 20, 2026; FDA proposed July 20, 2028, and Congress separately directed FDA not to enforce before that date. The guide distinguishes those legal facts from Mirelis’s recommended work sequence.

Broader regulatory action brief

14 workstreams + 30/60/90 action board

Industry programs & frameworks companion

9 voluntary programs retailers watch