All terms
RegulatoryRegulated Pathways
Intended Use
The objective intent of the manufacturer regarding the use of the device.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
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. What the regulation says
Under the US FDA, intended use refers to the objective intent of the persons legally responsible for the labeling of devices (21 CFR 801.4). This objective intent is determined by the expressions of the manufacturer or their authorized representative, including labeling claims, advertising, and promotional materials. Similarly, the EU MDR (Regulation (EU) 2017/745) defines intended purpose as the use for which a device is intended according to the data supplied by the manufacturer in the labeling, instructions for use, or promotional materials.What this means in practice
Intended use defines the device, drives classification, and is the anchor for risk analysis and labeling. Off-label promotion is a regulatory violation.Examples
- A manufacturer states their software is intended to assist clinicians in diagnosing melanoma from dermatoscopic images, which defines its intended use.
- A blood glucose meter is marketed for self-monitoring by individuals with diabetes, establishing its intended use for patient management of a chronic condition.
- An orthopedic implant
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.
Frequently asked questions
Intended use describes the general purpose of the device (e.g., to diagnose a condition), while indications for use specify the particular disease or condition the device will diagnose, treat, or prevent, and often include patient populations or anatomical sites.
Related terms
Shared paths + categoryRegulatory
Indications for Use(IFU (statement))
Description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate.
510(k) Fundamentals · adjacentDe Novo & Breakthrough Pathways · adjacent
Regulatory
Labeling
All written, printed, or graphic matter on or accompanying a device.
Same category
Regulatory
Substantial Equivalence(SE)
The legal standard a 510(k) device must meet versus a predicate.
510(k) Fundamentals · adjacentDe Novo & Breakthrough Pathways · adjacent
Regulatory
510(k) Premarket Notification(510(k))
FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
510(k) FundamentalsDe Novo & Breakthrough Pathways
Regulatory
De Novo Classification Request(De Novo)
Pathway to classify novel low- to moderate-risk devices that lack a predicate.
510(k) FundamentalsDe Novo & Breakthrough Pathways
Regulatory
Predicate Device
A legally marketed device used as the comparator in a 510(k) submission.
510(k) FundamentalsDe Novo & Breakthrough Pathways
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Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
eCFR·1European Commission·1IMDRF·1
- 121 CFR 801.4VerifiedeCFRecfr.gov
- 2European Commission - Medical DevicesVerifiedEuropean Commissionhealth.ec.europa.eu
- 3IMDRF DocumentsVerifiedIMDRFimdrf.org
Inline markers like [1] jump to the matching reference above.