FDA Compliant Medical Device Advertising: What the Rules Say

Medical device advertising stays within FDA and FTC rules when it claims only what the device is cleared, approved or otherwise authorized to do, gives the risk information a reader needs alongside the benefits, and never suggests that a 510(k) clearance is an FDA approval. The rules behind that sentence come from six primary sources: 21 CFR Part 801 on labeling and intended use, 21 CFR 807.97 on how a 510(k) may be described, FDA's draft guidance on presenting risk information in device promotion, the FTC's Endorsement Guides for testimonials and paid endorsers, section 502(q) and (r) of the Federal Food, Drug, and Cosmetic Act on restricted device advertising, and section 12 of the FTC Act on false advertising. This page walks through what each source says, quotes the sentence that matters, and ends with a checklist to run before an ad goes live. It is written for device marketing directors who work with a regulatory team, not in place of one. Your regulatory and legal reviewers make the final call on every piece.

FDA does not review or approve device ads before they run. For restricted devices, the statute bars FDA from requiring prior approval of ad content except in extraordinary circumstances (21 U.S.C. 352(r)).

Which rules apply to medical device advertising

Who regulates a device ad depends on the device. FDA regulates advertising for restricted devices: under section 502(q) and (r) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(q) and (r)), a restricted device is misbranded if its advertising is false or misleading, and every ad for it must include the device's established name and a brief statement of its intended uses and relevant warnings, precautions, side effects and contraindications. Advertising for other devices falls under the Federal Trade Commission, and section 12 of the FTC Act (15 U.S.C. 52) makes it unlawful for that advertising to be false. FDA's labeling rules, including the intended use rule below, apply to every device. Whether your device is a restricted device is a question for your regulatory lead. FDA's risk guidance describes itself as covering promotional labeling for devices and advertisements for restricted devices.

What you say in an ad counts as evidence of what your device is for

FDA's intended use regulation says a company's intent "may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives" (21 CFR 801.4). In plain terms, your ads, your website and what your sales reps say can all be used as evidence of the uses you intend for the device.

That is why every ad should be checked against the indication in your clearance or approval. If an ad names a patient group, a procedure or a result that the indication does not cover, the ad can be read as evidence that you intend that use.

"FDA cleared" versus "FDA approved"

21 CFR 807.97 says a 510(k) clearance "does not in any way denote official approval of the device," and that "any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding."

For a 510(k) device, write "FDA cleared." Check headlines, image text, video captions, social posts and sales slides for "FDA approved," because that phrase tends to reappear when copy is shortened.

Comparing your device to a competitor

21 CFR 801.6 says that "a false or misleading representation with respect to another device or a drug or food or cosmetic" in a device's labeling makes the device misbranded, and the FTC Act bars false advertising. So any comparison with a competitor's product needs evidence that supports it before the piece runs, the comparison should claim no more than that evidence shows, and your regulatory team should review both.

How to present risk information

FDA's draft guidance on presenting risk information is marked "Not for implementation. Contains non-binding recommendations." It still shows how FDA looks at a promotional piece, and three points in it are useful for any ad review.

• FDA looks at the whole piece. The guidance says FDA looks "not just at specific risk-related statements, but at the net impression," meaning the message the whole piece sends.
• Risk information belongs in the main part of the piece. The guidance says "risk information should be included in the main part of a piece."
• Benefits and risks should get comparable prominence. The guidance gives "presenting several pages of benefits before any risks" as one example of a lack of appropriate prominence.

Labeling that gives use information must include risk information

For prescription devices, 21 CFR 801.109(d) makes it a condition of the prescription device exemption that any labeling that "furnishes or purports to furnish information for use of the device" contains adequate information for that use, "including indications, effects, routes, methods, and frequency and duration of administration and any relevant hazards, contraindications, side effects, and precautions."

The same paragraph exempts so-called reminder pieces, which call attention to the name of the device but do not include indications or other use information. Once a piece includes indications or any other information about how the device is used, the regulation no longer treats it as a reminder piece. This exemption is in the labeling rule; it does not excuse an ad for a restricted device from the requirements in 21 U.S.C. 352(r).

Testimonials and paid surgeon endorsements

The FTC's Endorsement Guides apply to testimonials from patients, surgeons and other users. Four rules from them come up most often in device marketing.

1. Endorsements must be honest. "Endorsements must reflect the honest opinions, findings, beliefs, or experience of the endorser" (16 CFR 255.1(a)).
2. A patient testimonial is a performance claim. A testimonial about how a product performs "will be interpreted as representing that the product is effective for the purpose depicted," so you need the same evidence you would need to make that claim yourself, and "[c]onsumer endorsements themselves are not competent and reliable scientific evidence" (16 CFR 255.2(a)). A testimonial about a key attribute "will likely be interpreted as representing that the endorser's experience is representative of what consumers will generally achieve" (16 CFR 255.2(b)). If you cannot support that, the Guides say the ad should clearly and conspicuously disclose the generally expected performance, you must be able to support that disclosure too, and the disclosure must change the overall impression of the ad.
3. Paid relationships must be disclosed. A connection between the endorser and the seller that "might materially affect the weight or credibility of the endorsement," and that the audience would not expect, "must be disclosed clearly and conspicuously." The Guides list "monetary payment or the provision of free or discounted products" among such connections (16 CFR 255.5(a)).
4. Expert endorsers need the expertise they are presented as having. If an ad presents the endorser as an expert, "the endorser's qualifications must in fact give the endorser the expertise that the endorser is represented as possessing" (16 CFR 255.3(a)).

The Guides also say advertising agencies "may be liable for their roles in creating or disseminating endorsements containing representations that they know or should know are deceptive" (16 CFR 255.1(f)). That applies to agencies like mine as well as to your company.

A checklist to run before a device ad goes live

1. Does every claim in the ad match the indications for use in your clearance, approval or De Novo grant, and your cleared labeling?
2. Does the ad say "FDA cleared" for a 510(k) device and never "FDA approved"?
3. Does the page the ad links to say the same thing as the ad?
4. For a restricted device, does every ad include the established name and a brief statement of intended uses and relevant warnings, precautions, side effects and contraindications (21 U.S.C. 352(r))? For any other device, does the ad itself give the risk information a reader needs to judge its claims, in the main part of the piece, with fuller information on the page it links to?
5. Is every comparison with another product supported by evidence before the piece runs, claiming no more than that evidence shows, and reviewed by your regulatory team?
6. Is every testimonial the endorser's own honest experience, and do you have support for the results it implies?
7. Is any payment, free product or other connection between an endorser and your company disclosed where the audience will see it?
8. Has your regulatory or legal reviewer signed off, and is the sign-off dated and filed with the final version?

How I handle claims review on client work

On device client work, I check ads against the client's cleared indication before they go to the client's regulatory or legal reviewer, and I keep a record of which source supports each claim. A reviewer can check a line without asking me where it came from. I am not regulatory counsel, and my review does not replace yours. It is meant to make your reviewer's job shorter.

For the difference between clearance, approval and De Novo in more detail, see FDA cleared vs FDA approved for medical device marketing.