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First-in-Human Study

First clinical use of a device or therapy in humans, often outside the U.S. before a U.S. EFS.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

Definition

FIH studies generate the earliest human safety and feasibility data and frequently inform IDE submissions. Many FIH studies are conducted under EU CIPs or in OUS jurisdictions like Australia, Latin America, or New Zealand.

What this means in practice

Choice of FIH geography is a strategic decision balancing cost, IRB/EC speed, follow-up reliability, and FDA's view of the resulting evidence.

Primary references

3 sources

Link health: 3 verified· last checked 2026-05-09

ICH·2ISO·1

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On this term

Category: Clinical & Trials
Acronym: FIH
Sources: 3
Updated: 5/5/2026

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Learn in 60 seconds

First clinical use of a device or therapy in humans, often outside the U.S. before a U.S. EFS.

·Choice of FIH geography is a strategic decision balancing cost, IRB/EC speed, follow-up reliability, and FDA's view of the resulting evidence.
·Many FIH studies are conducted under EU CIPs or in OUS jurisdictions like Australia, Latin America, or New Zealand.

Remember this

First clinical use of a device or therapy in humans, often outside the U.S. before a U.S. EFS.

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