The PMOA rule
The PMOA rule: the marketing application coincides with the Primary Mode of Action; a single application is generally appropriate.
Free field guide · PDF
FDA Combination Products2026 Field Guide
The PMOA rule, the device-led paths, and the 2026 overlays — with the FDA practice you need.
- App type
- PMOA
- Application
- 1
- Overlays
- 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 device-led paths
The device-led paths: PMA, De Novo, and the hard 510(k) fit — plus streamlined review via reliance on prior findings.
The 2026 overlays
The 2026 overlays: QMSR cGMP × ISO 13485, the URRA human-factors mandate, and the finalized UDI combo guidance.
Sources & scope
- propharmagroup.com, FDA Issues Draft Guidance to Advance Development of Combination Products.
- cmhealthlaw.com, FDA Finalizes Guidance on Combination Products.
- medium.com, Navigating the 2026 Overhaul: Drug-Device Combination Products.
This guide is market-access intelligence, not regulatory or legal advice. FDA combination-product guidance, PMOA determinations, and review practice change — professional review is required before business use.
Market Access Strategy Session
Combination product on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your combo route — PMOA positioning, pathway strategy, and the 2026 overlays.
Professional review is required before business use.
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