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    Indications for Use

    Description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate.

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

    Definition

    The Indications for Use statement is a specific statement of disease, condition, or anatomical site for which a device is intended, including the patient population.
    What the regulation says
    The FDA defines "Indications for Use" as a statement describing the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including the target patient population, as detailed in 21 CFR 814.20(b)(3)(i) for PMAs and 21 CFR 807.87(e) for 510(k) submissions. This statement establishes the boundaries for a device's permitted use and is a critical component of its regulatory submission and labeling.

    What this means in practice

    Indications for Use is a specific, regulatorily significant subset of intended use, captured in 510(k) and PMA decision summaries.

    Examples

    • A continuous glucose monitor's Indications for Use state: "For use by people age 18 years and older with diabetes mellitus for the management of their diabetes through the measurement of glucose levels in interstitial fluid."
    • A surgical robot's Indications for Use specifies: "Intended for use in general laparoscopic surgical procedures to assist in the precise manipulation of instruments and visualization of the surgical field."
    • An in vitro diagnostic test's Indications for Use might declare: "For the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen from nasal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset."
    Common pitfalls
    • •Confusing "Indications for Use" with "intended use" can lead to mislabeling and regulatory non-compliance.
    • •Failing to precisely define the patient population or conditions can result in a device being used off-label, creating safety risks.
    • •Inconsistent Indications for Use across different official documents, such as regulatory submissions and marketing materials, can trigger regulatory scrutiny.
    • •Not clearly delineating the specific disease or condition the device addresses can lead to ambiguity in its application and efficacy claims.
    • •Omitting contraindications or warnings within the labeling related to the Indications for Use can result in adverse events and regulatory actions.

    Frequently asked questions

    Indications for Use are a specific subset of intended use, detailing the medical conditions or purposes for which a device is intended. Intended use is a broader concept encompassing the general purpose of the device and how it achieves its function.
    Grouped by theme

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    European Commission·1IMDRF·1RAPS·1
    1. 1
      European Commission - Medical Devices
      Verified
      European Commissionhealth.ec.europa.eu
    2. 2
      IMDRF Documents
      Verified
      IMDRFimdrf.org
    3. 3
      RAPS Regulatory Focus
      Verified
      RAPSraps.org

    Inline markers like [1] jump to the matching reference above.