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    Clinical & TrialsClinical EvidenceFIH

    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. FIH studies usually enroll a small number of subjects under close monitoring, with strict stopping rules and careful site selection. Their nonclinical package typically includes bench, animal and biocompatibility testing. FDA accepts data from studies outside the US if they follow good clinical practice under 21 CFR 812.28, which matters when early data from OUS sites is used to support a US IDE.
    What the regulation says
    First-in-Human (FIH) studies are typically conducted under an Investigational Device Exemption (IDE) in the United States, as outlined in 21 CFR Part 812, or through similar regulatory frameworks internationally, such as those governed by the EU Medical Device Regulation (EU MDR) for Clinical Investigations. These studies are crucial for gathering initial safety and performance data in humans, supporting subsequent regulatory submissions. The International Medical Device Regulators Forum (IMDRF) provides guidance on clinical evidence for medical devices, which often includes considerations for early feasibility studies like FIH.

    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.

    Examples

    • A MedTech company conducts an FIH study in Australia for a new implantable cardiac monitor, collecting initial safety data on biocompatibility and device functionality over a 3-month period.
    • An innovative surgical robot undergoes an FIH study in Belgium under an EU Clinical Investigation Plan, focusing on the acute safety of the device during its first uses in human patients.
    • A novel neurostimulation device intended to treat chronic pain initiates an FIH study in New Zealand to evaluate initial device tolerability and capture preliminary efficacy signals.
    Common pitfalls
    • •A common pitfall is failing to establish clear go/no-go criteria before initiating an FIH study, leading to prolonged or inconclusive trials.
    • •Another mistake is underestimating the complexity of patient recruitment and retention in early-stage studies.
    • •Inadequate consideration of global regulatory acceptance of FIH data can lead to difficulties in leveraging study results for multiple market approvals.
    • •Failing to implement robust data collection and management systems from the outset can compromise data integrity and regulatory submission quality.

    Frequently asked questions

    The primary objective of an FIH study is to assess the initial safety and preliminary performance of a novel MedTech device in human subjects. This includes identifying potential adverse events and understanding basic device function in a clinical setting.

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    Sources

    3 sources

    Sources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

    Tier 1Binding law and standards· 1Tier 2Regulator guidance and consensus· 2
    Link health: 3 verified· last checked 2026-06-20
    ICH·2ISO·1
    1. 1
      ICH E11A FIH
      Tier 2 Verified
      ICHich.org
    2. 2
      ICH Guidelines
      Tier 2 Verified
      ICHich.org
    3. 3
      ISO 14155 Standard Page
      Tier 1 Verified
      ISOiso.org

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