Regulatory Claim vs Marketing

A regulatory claim is a statement about what a regulator has permitted a device to be marketed for. A marketing claim is a statement a company chose to make about what the device will do for you. They look alike on a web page and they carry completely different weight.

You can separate them in a few seconds once you know what to look at. The tests below are the ones we use on our own copy before it goes live.

What is the fastest single test?

Look for the word cleared and check what it is attached to. A regulatory statement attaches to a specific device and a specific indication, and it reads like a filing. A marketing statement attaches to you and your week.

Compare these two shapes. The device is cleared for relaxation training and muscle reeducation. That is a regulatory statement, narrow and checkable. Our sessions will change how you feel within three visits. That is a marketing statement, and no regulator has been anywhere near it.

If a sentence contains a promise about your outcome, it is not a regulatory statement no matter how many regulatory words surround it.

Why does the difference between cleared and approved matter?

Because they describe two different levels of evidence and two different processes, and using the stronger word for a device that went through the lighter process overstates the record.

Clearance generally rests on showing that a device is substantially equivalent to one already on the market. It is a real review with real requirements, and it is not the same thing as a full premarket evidence review.

Our device clearance page explains the distinction properly, including which phrase is the correct one for a biofeedback device of this kind. If a provider uses the stronger word casually, that is a signal about how carefully they write everything else.

What phrases should make you slow down?

Any phrase that converts a narrow permission into a broad benefit. Watch for words that smuggle certainty into a sentence that has not earned it.

None of these phrases are automatically dishonest. Some are careless rather than deliberate. Either way they tell you that the person writing the page is not being careful with language, and language is the only thing you have to go on before you book.

How do you check a claim in under five minutes?

Ask what the claim would look like if it were false. A checkable claim has a version that fails. The device carries a signal measured in millionths of an amp is checkable, because a specification either says that or it does not.

Then look for the noun that the claim is about. Regulatory statements are about devices. Study findings are about populations. Marketing claims are about you. Statements about you are the weakest of the three and the most common.

Finally, look at what the page does not say. A careful practice publishes its limits somewhere visible. A page with no limits section anywhere on the site has made an editorial decision, and you can read it as one.

What does a careful sentence look like?

Narrow, sourced, and boring. Careful sentences name the thing, state the scope, and stop. They rarely feel exciting to read, which is part of why they are less common than they should be.

Here is a careful version and a careless version of the same underlying fact. Careful: the device we use is an FDA-cleared biofeedback device indicated for relaxation training and muscle reeducation. Careless: the device is an FDA-cleared brain wellness system for stress and focus.

The second sentence adds two categories nobody cleared and quietly attaches them to the regulator. That is the whole trick, and once you see it you will see it everywhere.

How do we apply this to our own writing?

With a list of words this site is not permitted to use, checked automatically before a build succeeds. The list includes outcome verbs, certainty words, percentages presented as results, and any pairing of a health condition with a benefit.

That check is not a marketing decision. It exists because a wellness practice using a cleared biofeedback device has a narrow lane to write in, and a person writing at speed will drift out of it without noticing.

The consequence is that some of our pages read flatter than a competitor's. We would rather be flat and accurate. If you want to hold us to it, our standards page states the rules in public so they can be checked against what we actually publish.

What should you ask a provider directly?

Ask what the device is cleared for, in the exact words on the filing. A provider who knows will answer in one sentence. A provider who does not will change the subject to how people feel afterwards.

Then ask what they will not claim. It is an unusual question and the answer is revealing. Somebody with real standards has a list ready, because they have had to enforce it against their own copy.

What does this look like applied to a single sentence?

Take a sentence built from a device indication and a hopeful noun. The regulatory half is checkable against a public record. The hopeful half is not checkable against anything, and the sentence borrows credibility from the first part to carry the second.

Splitting a sentence in half is the fastest test available to a reader. Underline the part that could be verified by a third party, then read what is left on its own and see whether it still says anything.

Do the same exercise on this page if you like. The sentences here that describe a room, a duration, or a regulatory category are checkable. The ones describing what people report are not, and we have tried to mark that difference in the wording rather than hide it.