--- title: "Label Claims, Definition | MedTech Terms" description: "Indications, performance, and other statements approved or cleared for labeling. Plain-English Commercialization definition for MedTech teams, with examples and" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/label-claims#term", "name": "Label Claims", "description": "Label claims are the statements about intended use, indications, contraindications, warnings, and performance that the FDA has cleared/approved for inclusion in labeling. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Commercialization](/terms?cat=Commercialization) 6. / 7. Label Claims [All terms](/terms) Commercialization [Hospital Buyer & Reimbursement](/ecosystems/hospital-buyer) # Label Claims Indications, performance, and other statements approved or cleared for labeling. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Label claims are the statements about [intended use](/terms/intended-use), indications, contraindications, warnings, and performance that the FDA has cleared/approved for inclusion in [labeling](/terms/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](/terms/intended-use), indications, contraindications, warnings, and performance are substantiated by scientific evidence and clinical data. The EU [MDR](/terms/mdr-reporting), 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](/terms/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 What is the primary purpose of label claims in MedTech? The primary purpose of label claims is to inform users, including healthcare professionals and patients, about the [safe](/terms/safe-note) and effective use of a medical device, based on scientific evidence accepted by regulatory authorities. What happens if a manufacturer promotes a device for an 'off-label' use? How do label claims relate to a device's intended use? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Commercialization Off-Label Use Use of a device for an indication not in its cleared/approved labeling. ](/terms/off-label-use) ### More in Commercialization · Same category [ Commercialization AdvaMed Code of Ethics Industry code governing interactions between U.S. medical-device companies and healthcare professionals. ](/terms/advamed-code)[ Commercialization Advisory Board Convening of external experts to advise on strategy or product. ](/terms/advisory-board)[ Commercialization Anti-Kickback Statute(AKS) U.S. criminal statute prohibiting remuneration to induce federal healthcare business. ](/terms/anti-kickback)[ Commercialization Bottom-Up Market Sizing Building market size from procedure volumes × price × penetration. ](/terms/bottom-up-sizing) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Hospital Buyer & Reimbursement](/ecosystems/hospital-buyer) ## Primary references 2 sources Link health: 2 verified · last checked 2026-06-20 AdvaMed· 1 AHRMM· 1 1. [1 AdvaMed Code of Ethics Verified AdvaMed · advamed.org ](https://www.advamed.org/our-work/code-of-ethics/) 2. [2 AHRMM - Healthcare Supply Chain Verified AHRMM · ahrmm.org ](https://www.ahrmm.org/) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Selling a connected device into health systems? Hospital procurement increasingly requires MDS2, SBOM, and security questionnaires - we help your team answer them confidently. [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 Commercialization Sources 2 Updated 5/5/2026 [Compare with another term](/compare?a=label-claims) Learn in 60 seconds Card Lesson Quiz Indications, performance, and other statements approved or cleared for labeling. - · Salesforce training, marketing collateral, and KOL speaker decks must align with cleared label. - · Promotion outside the label triggers warning letters and DOJ exposure. - · Off-label promotion is prohibited. Remember this Watch out: 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. Related terms - [Off-Label Use ](/terms/off-label-use) You may also need Auto-suggested from Commercialization and shared keywords. - [Instructions for Use(IFU) ](/terms/ifu) - [ISO 15223-1 Symbols ](/terms/iso-15223-1) - [Special Controls ](/terms/special-controls) - [Freedom to Operate(FTO) ](/terms/freedom-to-operate) - [Physician Training and Proctoring ](/terms/training-and-proctoring) - [Quality System Regulation(QSR / 21 CFR 820) ](/terms/qsr) [All Commercialization terms](/terms?cat=Commercialization) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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