How Buzzbox Media checks marketing claims against your FDA clearance

The five steps

1. Find the cleared indication. The check starts with the clearance itself: the 510(k), De Novo or PMA number, the indications for use, the product code and the regulation the device falls under, read from FDA's public database and your clearance letter. For a 510(k)-exempt device, it starts with the regulation that exempts it and the limits that come with that exemption.
2. List every claim beside it. Every statement about what the device does, who it is for, how well it works or what it works with is listed next to the cleared indication. That includes headlines, captions, image descriptions, page titles, ad text, catalog copy and the descriptions Google and AI assistants read.
3. Match each claim to its evidence. A claim inside the indication still needs support. Performance numbers are traced to the test report, study or labeling they come from. A claim with no source on file is not used until one is supplied.
4. Write the wording that passes the check. Each claim gets one of three results: it passes as written, it is rewritten to stay inside the clearance and the evidence, or it is held for your regulatory reviewer to decide. Rewrites are given word for word, so your team can approve or change them. Passing means the wording matches the clearance and the evidence on file as Buzzbox Media reads them. Your regulatory reviewer has the final say.
5. Keep the record. The approved wording, its source, the date and who approved it go into the claims sheet. New pages and ads are written from that sheet, and when the clearance, the labeling or a ruling changes, the sheet is updated before any page is.

The rules the check follows

• What a device is intended for is judged by what the company says about it, including its labeling, its advertising, and what the company and its representatives say or write (21 CFR 801.4).
• Labeling that is false or misleading in any way misbrands a device (21 U.S.C. 352(a)).
• A major change in a cleared device's intended use needs a new 510(k) (21 CFR 807.81(a)(3)(ii)). Marketing a use that needs a clearance or approval the device does not have is what most FDA warning letters about device marketing cite (21 U.S.C. 351(f)(1)(B) and 352(o)).
• A 510(k) clearance does not mean FDA approved the device, and FDA registration does not mean FDA approved anything. Saying or implying either is misleading (21 CFR 807.97 and 807.39).
• For a device exempt from 510(k), the exemption ends where the marketing describes a use that differs from the device type (the limits in 21 CFR 862.9 through 892.9).

An example (illustrative)

This example describes a common type of device and claim. It is not taken from any company's materials.

The device: software cleared through 510(k) to display and measure medical images for review by trained clinicians.

Each row then goes into the device's claims sheet with its source (the clearance summary, the test report or the labeling page) and the date.

What FDA objected to most in 2025

In 2025, FDA issued 28 warning letters that cited how a medical device or a product sold as one was marketed, by Buzzbox Media's count. Twelve went to sellers of breast binders on one day, December 16; the other 16 went to device companies.

How this was counted. Buzzbox Media read each FDA warning letter dated January 1 to December 31, 2025 on fda.gov and counted those that cite a company's own website, brochure, labeling, video, talk or store listing as showing a use, a claim or an FDA status the product did not have. Letters about factory, quality or reporting problems only are not counted. Each letter is counted once, under its main problem. Counted November 9, 2026; FDA posts some letters months after they are dated, so the total can still change. Reviews that use other definitions report different totals.

Source: FDA Warning Letters database. Every letter, with a link: FDA warning letter tracker.

Who does the check, and when

Buzzbox Media builds the claims sheet at the start of every program, from your clearance and labeling, before any marketing is written. Every draft is checked against the claims sheet before it reaches you, and Baron Miller reviews it before it is sent. Your regulatory or legal reviewer decides anything held and signs off wherever your process requires it.