Intended use is the use for which a product is intended according to the data supplied by the manufacturer in labeling, advertising, and promotional materials. Intended use is determined by the manufacturer's objective intent, shown through labeling, claims, advertising and statements by representatives, as described in 21 CFR 801.4. It drives classification and the regulatory pathway, so a change in claims can turn a cleared device into one that needs a new submission. The EU MDR uses the closely related term 'intended purpose', defined in Article 2(12).

Why it matters

Intended use defines the device, drives classification, and is the anchor for risk analysis and labeling. Off-label promotion is a regulatory violation.

Common pitfalls

•A poorly defined intended use can lead to incorrect device classification, impacting regulatory pathway and submission requirements.
•Failing to clearly articulate the intended use can result in inadequate risk management activities, as potential hazards may be overlooked.
•Marketing or promoting a device for uses outside its stated intended use constitutes off-label promotion, which is a regulatory violation.
•Modifying the intended use of a device without proper regulatory notification or submission can lead to non-compliance and enforcement actions.
•Overly broad or vague intended use statements can create ambiguity and make it difficult to demonstrate conformity with essential requirements or safety and performance principles.

Sources

21 CFR 801.4 · eCFR
European Commission - Medical Devices · European Commission
IMDRF Documents · IMDRF

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Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
EU frameworks - MDR vs IVDR, CE Mark vs UKCA.
Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

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MedTech Terms is a vendor-neutral community resource sponsored by Blue Goat Cyber. Definitions are written for educational use and are not legal or regulatory advice.