--- title: "FIH, First-in-Human Study | MedTech Terms" description: "First clinical use of a device or therapy in humans, often outside the U.S. before a U.S. EFS. Plain-English Clinical & Trials definition for MedTech teams, wit" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/fih#term", "name": "First-in-Human Study", "alternateName": "FIH", "description": "FIH studies generate the earliest human safety and feasibility data and frequently inform IDE submissions. 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Comprehensive informed consent processes and rigorous Institutional Review Board (IRB) or Ethics Committee (EC) oversight are paramount, often following principles outlined in ISO 14155, Clinical investigation of medical devices for human subjects, Good clinical practice." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Clinical & Trials](/terms?cat=Clinical%20%26%20Trials) 6. / 7. First-in-Human Study [All terms](/terms) Clinical & Trials [Clinical Evidence](/ecosystems/clinical-evidence)FIH # 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 Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition FIH studies generate the earliest human safety and feasibility data and frequently inform [IDE](/terms/ide) submissions. Many FIH studies are conducted under EU CIPs or in OUS jurisdictions like Australia, Latin America, or New Zealand. What the regulation says First-in-Human (FIH) studies are typically conducted under an [Investigational Device Exemption](/terms/ide) (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](/terms/mdr) (EU [MDR](/terms/mdr-reporting)) 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](/terms/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](/terms/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 What is the primary objective of a First-in-Human study? 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. How do FIH studies relate to an IDE submission? Are there specific ethical considerations for FIH studies? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Clinical & Trials Early Feasibility Study(EFS) FDA program enabling early human evaluation of novel devices with limited preclinical data and iterative design. ](/terms/efs)[ Clinical & Trials Investigational Device Exemption(IDE) FDA authorization to use an investigational device in a clinical study. ](/terms/ide) ### More in Clinical & Trials · Same category [ Clinical & Trials Adaptive Trial Design Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data. ](/terms/adaptive-trial)[ Clinical & Trials Adverse Event(AE) Any untoward medical occurrence in a subject, whether or not related to the device. ](/terms/adverse-event)[ Clinical & Trials ALCOA+ Data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate (plus Complete, Consistent, Enduring, Available). ](/terms/alcoa-plus)[ Clinical & Trials Analytical Sensitivity An IVD's ability to detect small quantities of an analyte. ](/terms/analytical-sensitivity) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Clinical Evidence](/ecosystems/clinical-evidence) ## Mentioned in recent activity 1 entry PubMed (1) [Assessing the Diagnostic Performance of a Smart Bra Using Temperature and Bioimpedance for Breast Cancer Detection: A First-in-Human Study. ](https://pubmed.ncbi.nlm.nih.gov/42122592/) Sensors (Basel, Switzerland) · 2026-05-04 ## Latest in MedTech [View all](/latest?term=fih) Recent regulatory actions, publications, and trials matched to this term. Updated daily. - PubMed 2026-05-04 [Assessing the Diagnostic Performance of a Smart Bra Using Temperature and Bioimpedance for Breast Cancer Detection: A First-in-Human Study. ](https://pubmed.ncbi.nlm.nih.gov/42122592/) Sensors (Basel, Switzerland) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ICH· 2 ISO· 1 1. [1 ICH E11A FIH Verified ICH · ich.org ](https://www.ich.org/) 2. [2 ICH Guidelines Verified ICH · ich.org ](https://www.ich.org/page/ich-guidelines) 3. [3 ISO 14155 Standard Page Verified ISO · iso.org ](https://www.iso.org/standard/71690.html) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Clinical evidence intersecting with device security? We support clinical-stage MedTech teams whose investigational devices touch patient data or hospital networks. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Clinical & Trials Acronym FIH Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=fih) Learn in 60 seconds Card Lesson Quiz 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 Watch out: A common pitfall is failing to establish clear go/no-go criteria before initiating an FIH study, leading to prolonged or inconclusive trials. Related terms - [Early Feasibility Study(EFS) ](/terms/efs) - [Investigational Device Exemption(IDE) ](/terms/ide) You may also need Auto-suggested from Clinical & Trials and shared keywords. - [Feasibility Study ](/terms/feasibility-study) - [Electronic Data Capture(EDC) ](/terms/edc) - [Performance Study Application (IVDR) ](/terms/ivdr-performance-study-application) - [Bayesian Trial Design ](/terms/bayesian-trial) - [Clinical Evaluation Plan(CEP) ](/terms/clinical-evaluation-plan) - [Clinical Evaluation Report(CER) ](/terms/cer) [All Clinical & Trials terms](/terms?cat=Clinical%20%26%20Trials) From the Blue Goat network Related resources and services on this topic. - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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