While medical devices themselves are regulated by the U.S. Food and Drug Administration (FDA), advertisers of medical devices face additional scrutiny when marketing their products. In addition to complying with FDA regulations, including acquiring the appropriate clearances, medical device advertising can be reviewed by the Federal Trade Commission (FTC) and BBB National Programs’ National Advertising Division (NAD), and is subject to truth-in-advertising principles set by the FTC. In addition to express claims, marketers are responsible for all the messages reasonably conveyed to consumers in their advertising and should ask some important questions to ensure consumers are not misled. 

Medical devices include a diverse range of products, such as surgical masks, respirators, blood glucose monitors, and pacemakers, as well as artificial limbs and other implants. The FDA defines medical devices as any “instrument, apparatus, implement, machine, contrivance” which is “intended to affect the structure or any function of the body.” 

Most NAD cases arise when a company challenges the advertising of a competitor. And most of those challenges for medical devices have addressed whether the evidence that was sufficient for regulatory clearance by the FDA is also a good fit for all the messages conveyed by the advertising claims. The questions and answers below can help guide best practices for advertising medical devices to avoid conveying misleading messages.  

1. Are you advertising? 

Beyond television commercials, print ads, digital advertising, and social media posts, advertising can include communications between medical device sales representatives and healthcare professionals. These communications, formal or informal, in writing or in oral presentations, may be advertising. If so, the claims made in those communications require appropriate substantiation. 

Even a contractual promise that a device will provide a specific health outcome can be an advertising claim, particularly when taken together with representations made by a sales representative during the process of negotiating the contract. A claim like “heals faster,” when combined with a contract that promises benefits based on faster healing times, is an advertising claim that should be supported with competent and reliable scientific evidence.

2. Is your advertising limited to its FDA clearance and, if not, have you supported all express and implied messaged reasonably communicated? 

Claims cleared by the FDA will not be reevaluated in an NAD proceeding because NAD harmonizes its recommendations with the appropriate regulatory regime. Express and implied claims that promise benefits beyond those cleared by the FDA require their own scientific support. 

For example, in one NAD challenge, a medical device with an FDA 510(k) clearance for the temporary relief of pain or sore and aching muscles advertised it could treat neuropathy and provide long term pain relief. The product was not cleared to treat neuropathy or long-term pain relief. In that case, NAD determined that the evidence provided by the advertiser was not sufficiently reliable to support those claims. As a result, NAD recommended the claims be discontinued. 

In other cases, NAD has reviewed implied claims comparing two FDA-cleared products to determine whether the advertising conveyed a comparative message that one product performed better or faster than a competing product and recommended advertising changes when the implied message was not supported. 

For example, NAD determined that advertising comparing athlete’s foot products was misleading when the claims conveyed the message that one product worked faster than another, but their active ingredients and treatment times were the same. 

3. Do you possess competent and reliable scientific evidence that fits your claim? 

When advertising claims involve the efficacy of medical devices, human clinical trials that are methodologically sound and statistically significant to a 95% confidence level are generally required. For health-related claims, the FTC requires competent and reliable scientific evidence, a flexible yet rigorous standard that includes “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.” NAD generally requires the same level of support for health claims.

In addition to looking for statistical significance, NAD looks to whether the evidence also demonstrates that the results are large enough to impact the therapeutic outcome for consumers. Methodologically sound clinical studies of medical devices should ensure that the product that is currently on the market was the subject of the study and that the study:

• Included an appropriate sample population (for example, claims of neuropathy relief should be tested on people who have neuropathy),
• Included a control group and statistical plan,
• Was of sufficient duration, and
• Included an endpoint that fits the advertising claim (for example, relief claims for foot complaints would likely not be supported by back pain relief testing). 

Even if the results reach statistical significance, NAD will also look to whether the therapeutic effect of the results match the strength of the claimed benefits. Therefore, if an advertiser claims that its device will begin to relieve pain in 20 minutes, the pain relief at the 20-minute mark should be demonstrated to be noticeable and meaningful to consumers. 

Advertisers should also be careful with comparative claims. Most medical device clearances do not support comparative claims that a device performs better than a comparative product. Such comparative claims are health-related claims that require competent and reliable scientific evidence as support.  

Regulation vs Truth-in-Advertising 

As we mentioned above, regulation and self-regulation play different roles in protecting consumers. Beyond substantiating one’s own advertising, brands can challenge the veracity of their competitors’ health-related claims. Challenging a competitor’s advertising claim because a product failed to get FDA clearance is not an issue within NAD’s scope of review. Rather, challenging the reliability of evidence in support of an advertising claim is an issue NAD regularly reviews, including arguments that question the lack of fit between the evidence and the claim. 

At the end of the day, medical devices impact health, and health claims must be truthful, accurate, and well-supported. To avoid misleading messages, basic truthfulness in advertising rules of the road apply: know when you are advertising, identify all the messages reasonably conveyed by your advertising, determine the reliability of the evidence and whether it fits the claim, and ensure that the claimed health outcomes will be meaningful to consumers.