The draft best practices
The four draft best practices — well-established methods, safety/performance, no unmitigated issues, no design-related recalls — and what to write in the submission.
Free field guide · PDF
FDA 510(k): Predicate Selection2026 Field Guide
The draft best practices, the recall trap, and the QMSR gate — with the predicate practice you need.
- Best practices
- 4
- Clearance
- 90–180 days
- QMSR effective
- Feb 2026
Sourced from verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — verified 2026 publications.
The recall trap
Predicate creep, the JAMA 2023 Kadakia recall-chain data, and why the cleanest defensible predicate wins.
The QMSR gate
QMSR effective 2 February 2026 — why the distinct enforcement tracks still make design-control rigor your companion strategy.
Sources & scope
- afslaw.com (ArentFox Schiff), FDA Issues Draft Guidance on Best Practices for Selecting Predicate Devices.
- meddeviceguide.com, FDA 510(k) Predicate Best Practices: Recall History, Creep, and the 2026 QMSR Gate.
- cov.com (Covington), FDA Proposes Significant Shift to 510(k) Process in Draft Guidance.
This guide is market-access intelligence, not regulatory or legal advice. Predicate guidance, substantial-equivalence practice, and QMS enforcement change — professional review is required before business use.
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A Market Access Strategy Session maps your 510(k) strategy — predicate selection, eSTAR readiness, and QMSR compliance.
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