Branding, Medical & MedTech / Apr 4, 2025

Keeping Your Medical Device Marketing Aligned With Regulation

Rachael Sparks

Director, Medical Brands

If your medical technology is FDA regulated as a Class I, II, or III device, you are subject to increasingly stringent regulatory restrictions on your marketing. Each class is a more restrictive category relative to how much risk a patient might be in by use of the device. For class I, think Band-Aids™, class II IV pumps, and class III includes devices that are life-critical – synthetic heart valves or a brain stent.

The FDA imposes specific requirements on marketing claims for medical devices to ensure compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). These requirements are designed to prevent false or misleading information and ensure that claims align with the device’s approved or cleared uses. But in the world of marketing – branding, messaging, content, and packaging – it’s easy to mistakenly cross a line and imply your device can achieve something for which the FDA feels you lack evidence. Follow these 7 key marketing requirements, or make sure your marketing agency does, to stay on the FDA’s good side¹.

1. Truthfulness and Accuracy

Marketing claims must be truthful, not misleading or exaggerated, and supported by valid scientific evidence. Citations are sexy! And it works in reverse - claims can’t omit critical facts. Some companies maintain an internal MLR (medical, legal and regulatory) review committee to review new marketing materials with expert eyes before they are released. Your marketing agency may be able to provide this, but if not, consider creating a claims matrix, which benefits your sales and account managers also.

2. Substantiation

All claims, whether explicit or implied, must be substantiated by scientifically valid data, such as statistically sound clinical studies or peer-reviewed publications. A good example of a statistically unsound claim might be “SuperBest Med Device ends ingrown toenails.” While that might fly on Amazon, the FDA expects claims to be corroborated, for example “SuperBest Med Device reduces ingrown toenails by 95% in clinical trials.” Comparative claims (e.g., “best in class” or “more effective”) require head-to-head studies that directly evaluate the devices being compared under scientifically valid conditions. If you don’t have a clinical team, consultants abound to provide exactly that service.

3. Consistency with Labeling

The labeling for FDA-approved medical devices is approved by the FDA as part of the regulatory process. Your marketing must be consistent with the device’s approved labeling, including its intended use, indications, and patient population. Marketing materials can’t promote off-label uses or suggest new uses that are not included in FDA-approved labeling.

4. Risk-Benefit Balance

Promotional materials must present risks and benefits in a balanced manner to avoid misleading consumers about the safety or effectiveness of the device. This might be as simple as including in your copy that “Complications occurred in 2% of patients who received the BestEver Synthetic Heart Valve, including (the complications found in your study).” For restricted medical devices (those requiring prescriptions), advertising must include a brief statement of intended use along with relevant warnings, precautions, side effects, and contraindications. If you are selling a restricted medical device, your regulatory expert can provide this language for your marketing teams to use, and they should understand it’s not up for copyedits.

5. Prohibition of Misbranding

A device is considered misbranded if its advertising contains false or misleading statements about its safety, effectiveness, or performance. Comparative claims that misrepresent other devices can also lead to misbranding violations. This is quite an umbrella term, but following the prior 4 guidelines is essentially keeping you out of the rain. While it’s tempting to denigrate a competitor with marketing that highlights why you’re better, it’s a dangerous line to walk and you could be risking more than you’ll win back. The magic of a strong marketing team can help you wordsmith advertising that achieves comparison without compromising your FDA approval.

6. Monitoring Social Media and Online Content

Digital marketing materials are subject to FDA scrutiny. Companies must ensure that social media posts and online advertisements do not suggest off-label uses or make unsupported claims. While it’s challenging to maintain a steady cadence of social media presence and get each post reviewed critically, a claims matrix can equip your social media manager with all the wording and citations they need to accurately reflect your approved claims.

Following FDA’s guidelines for marketing isn’t hard, but it does require attentiveness by your marketing team or agency. Hold your teams accountable for knowing the rules and adhering, and hire an agency who sees medical marketing as a creative challenge, not a constraint.

1. You may have read that the FDA has recently lost a lot of staff. Whether or not you support that change, it’s unlikely to be permanent, and it doesn’t change the rules you play by. If your device will be on the market for more than 4 years, it will very likely be governed by a more robust regulatory oversight than the FDA of 2025. ↩︎

Rachael Sparks

Director, Medical Brands