MedTech Terms
    The authoritative reference
    All terms

    Label Claims

    Indications, performance, and other statements approved or cleared for labeling.

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

    Definition

    Label claims are the statements about intended use, indications, contraindications, warnings, and performance that the FDA has cleared/approved for inclusion in labeling. Off-label promotion is prohibited.
    What the regulation says
    Regulatory bodies like the FDA scrutinize medical device label claims as part of the premarket submission process, ensuring that all statements regarding intended use, indications, contraindications, warnings, and performance are substantiated by scientific evidence and clinical data. The EU MDR, in Annex I, also requires that information supplied with the device clearly states its intended purpose, indications, and any contraindications or warnings. Manufacturers must ensure that all promotional materials and activities strictly adhere to these approved claims to avoid enforcement actions.

    What this means in practice

    Salesforce training, marketing collateral, and KOL speaker decks must align with cleared label. Promotion outside the label triggers warning letters and DOJ exposure.

    Examples

    • A manufacturer states in marketing materials that a cleared surgical robot can be used for a new, unapproved type of procedure, which constitutes an off-label claim.During a sales presentation, a representative emphasizes an unapproved benefit of an implantable device to a physician, deviating from the approved label claims.
    • A company
    • s website features testimonials from patients describing uses of a diagnostic tool that are outside its cleared indications, indirectly promoting off-label use.
    Common pitfalls
    • •A common pitfall is the unauthorized expansion of marketing claims beyond what was specifically cleared or approved by regulatory bodies, leading to "off-label promotion."Misinterpreting clinical data to support broader label claims than the evidence actually demonstrates can result in regulatory non-compliance.Failing to update label claims when new safety information or performance data becomes available can lead to patient risk and regulatory sanctions.
    • •Using ambiguous or unsubstantiated language in labeling that could mislead users about a device's capabilities or safety is a significant pitfall.
    • •Not having a robust internal review process to ensure all marketing and sales teams are operating strictly within the confines of approved label claims can lead to inadvertent off-label promotion.

    Frequently asked questions

    The primary purpose of label claims is to inform users, including healthcare professionals and patients, about the safe and effective use of a medical device, based on scientific evidence accepted by regulatory authorities.
    Grouped by theme

    Primary references

    2 sources
    Link health: 2 verified· last checked 2026-06-20
    AdvaMed·1AHRMM·1
    1. 1
      AdvaMed Code of Ethics
      Verified
      AdvaMedadvamed.org
    2. 2
      AHRMM - Healthcare Supply Chain
      Verified
      AHRMMahrmm.org

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