When a trial is required
PMA and De Novo almost always; 510(k) sometimes — and the real price tag: median $3.1M and 31 months concept-to-clearance.
Free field guide · PDF
Medical Device Clinical Trials2026 Field Guide
When your device needs a trial, how to design one the FDA will accept, and what the new ISO 14155:2026 standard changes about running it.
- ISO 14155:2026 live
- Apr 2026
- Median 510(k) cost
- $3.1M
- Median to clearance
- 31 mo
Sourced from ISO 14155:2026 and FDA IDE practice.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — ISO 14155:2026 and FDA IDE practice.
Designing for FDA acceptance
Q-Sub before enrollment, endpoints that decide everything, statisticians at concept stage, and the IDE decision flavors.
What ISO 14155:2026 changes
Effective April 26, 2026 with no transition: new CECs, formalized DMCs, the estimand framework, and stronger consent rules.
Sources & scope
- MedDeviceGuide, GCP for medical device clinical trials: ISO 14155 and ICH E6(R3) in 2026.
- Clinical Trials BC, ISO 14155 fourth edition published — April 2026.
- Veranex, core clinical considerations for IDE success.
- Medical Design & Outsourcing, BCG/UCLA study on 510(k)/De Novo cost and time.
This guide is market-access intelligence, not clinical or regulatory advice. Trial requirements are product-specific — professional review is required before business use.
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