FDA intended-use claims checker

FAQ

What does “intended use” mean under FDA regulations?

21 CFR 801.4 defines intended uses as the objective intent of the persons legally responsible for the labeling of the product. That intent may be shown by their expressions, the design or composition of the article, or the circumstances surrounding its distribution, for example labeling claims, advertising matter, or oral or written statements by the company or its representatives.

Why do words like diagnose, treat and prevent matter?

The FD&C Act definition of a device (section 201(h)) turns on intended use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. Copy that uses these verbs can turn a non-device product into a device, or suggest a new or expanded use for a cleared device. Under 21 CFR 807.81(a)(3), a major change or modification in intended use requires a new 510(k).

Does a disclaimer like “not intended to diagnose” solve the problem?

Not on its own. Because 21 CFR 801.4 lets intent be shown by labeling, advertising, statements, design, and distribution circumstances, a disclaimer does not cancel disease claims made elsewhere on the site, in the IFU, or by sales staff. Make the claims themselves consistent with the intended use.

How does FDA’s general wellness policy fit in?

FDA’s guidance “General Wellness: Policy for Low Risk Devices” (reissued January 6, 2026) describes low-risk products intended only for general wellness use, such as maintaining or encouraging a healthy lifestyle, for which FDA does not intend to examine device compliance. Products intended for the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition fall outside that policy, so wellness copy has to stay clear of disease claims.

Is intended purpose treated similarly under the EU MDR?

Yes. EU MDR Article 2(12) defines intended purpose as the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use, in promotional or sales materials or statements, and as specified in the clinical evaluation. Article 7 prohibits labeling, instructions, and advertising that could mislead users or patients about the device’s intended purpose, safety, or performance.

What does this highlighter actually check?

It matches a fixed list of high-risk words and phrases (such as diagnose, treat, prevent, screen, and autonomous) in the text you paste. It does not detect implied claims, images, testimonials, or context, and a flagged word is not automatically a problem. Use it to decide which sentences need a regulatory review.