December 11, 2023

Overview of FDA Advertising and Promotion Regulations for Medical Devices

Marketing a medical device under intense scrutiny requires deep understanding of what you can safely claim about your product – and what you can’t. In this article, we’ll discuss the types of marketing and sales content that falls under regulatory oversight, how to comply with regulatory requirements when advertising your device, and how to manage claims being published by your team.

Advertising and marketing content are considered medical device labeling

Advertising and promotional materials fall under the umbrella of “labeling” by device regulators. Definitions of labeling in the EU and US refer to information on or accompanying the device related to its identification, technical description, or use, which explicitly includes advertising and promotional materials in both jurisdictions.

Labeling oversight extends to any information provided by your company associated with the device, including that which is provided digitally, such as:

Company websites
Videos
Advertising, promotional, and sales materials
Press releases
Social media advertising and posts

Misbranding is the FDA term for a product labeling issue. A device can be misbranded if any aspect of its labeling is “false or misleading.” False or misleading representations can be explicit or merely suggested, so be precise with your wording before, during, and after marketing authorization from the FDA. For example, medical device manufacturers sometimes get into hot water when an overeager marketing person uses the term “FDA approved” in marketing materials. The FDA is very explicit that it does not “approve” devices that go through the 510(k) process – they “clear” them to be legally sold. FDA “approval” is reserved for high-risk devices, most of which go through the Premarket Approval (PMA) process. Make sure your marketing department knows not to use the word “approved” together with FDA.

What about Europe?

On the European side, Article 7 of the EU MDR addresses medical device claims. It prohibits any labeling or advertising that might mislead the user or patient about the safety, function, or intended use of the device, specifically the intended use for which the device’s conformity assessment was completed.

Align medical device claims with intended use and indications for use

Your device intended use and indications for use are the backbone of all claims you will make about your device. You want to say as many good things as you can about your product without violating regulatory requirements so it’s important that you align sales or marketing language with the intended use and indications for use contained in your 510(k) or PMA, if applicable. Claims can be direct or implied and can appear anywhere, from online ads and YouTube videos to LinkedIn posts and tradeshow booths.

Intended use is the general purpose or function of a device.
Indications for use refers to the device’s specific clinical application(s), such as the disease or condition the device will diagnose, treat, cure, prevent, etc. in a target patient population. Ascribing a new or different intended use beyond the one addressed in your regulatory submission is considered outside the scope of your authorization and can trigger a response from regulators. You may have to submit another application to promote your product under the new intended use

Examples of FDA clamping down on medical device promotions

For example, following some design changes to the product, a promotional video for a hip cup replacement promoted it for cementless fixation (when new bone growth holds the implant in place). However, the FDA cleared the product for cemented fixation only (in which bone cement secures the implant). Cementless fixation introduces a new intended use, not to mention a different product code, which would likely require the manufacturer to seek a separate marketing authorization from the FDA.

Similarly, a low-level LED light therapy device was cleared by the FDA for the intended use of providing non-invasive dermatological treatment that reduces hip, waist, and thigh circumference. However, the company website and several social media posts claim the device can help treat neuropathy in “under 10 minutes.” A competitor company reported these claims and FDA issued a warning letter citing the unsupported intended use, as well as significant public health concerns for users seeking relief from neuropathy who may be at risk for burns or delayed treatment of a more critical underlying condition.

Advertising a medical device on social media

The informality and fast pace of social media make it easy for a marketing person to get “out in front of their skis,” as the old saying goes. Overzealous writers may modify claims wording to make it more compelling or fit character limits, distorting its meaning over time. Minor wording changes can be detrimental as well. For example, claiming a device “may” achieve a specific outcome is very different from claiming it “will” do something.

Regulators don’t have the bandwidth to read every social media post–and they don’t need to. Your competitors are watching you and will happily do the work for them. You can’t assume a subtle inaccuracy will go unnoticed. As such, close collaboration between regulatory and marketing is essential, especially when marketing on social media. Here are a few strategies to consider:

If you work in RA/QA, follow your own brand on social media so you can make sure marketing is not stretching the boundaries of your claims language.
Provide your team with a list of lawful claims they can confidently use to develop promotional content for your device.
Plan and review a social media content calendar in advance to ensure all claims are worded accurately and stated benefits include required risk information. Refer to FDA’s draft guidance Internet/Social Media Platforms with Character Space Limitations Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices for a closer look at these requirements.

When to correct misinformation about your device

Social media is fertile ground where misinformation about your device can spread. Not all misinformation is negative; however, even glowing reviews that overstate your product’s benefits can be harmful to the public. While you’re not responsible for all third-party claims, there may be circumstances in which your company needs to respond to misinformation generated by a third party or user (known as user-generated content or UGC).

For example, a social media influencer posts a review of your product using language that inaccurately characterizes its benefits, outcomes, or intended use. Is your company liable? If the influencer was paid by your company, their review is considered part of your product’s labeling and you are obligated to promptly remove and/or correct it. If the influencer was NOT paid by your company for their review, you’re under no obligation to correct the misinformation. Refer to FDA’s draft guidance on Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.

The EU MDR Is less explicit about guidelines for social media promotion. However, you should follow Member State advertising requirements where your device is sold and marketed. Additional requirements such as limitations on marketing devices that treat certain disease states, additional clinical data, text that must accompany online advertisements, etc. may apply. Also note that all advertising material may need to be translated into the Member State’s official language along with the rest of your labeling materials.

Keep track of claims made in marketing materials

Any claims about your product should be supported by scientific evidence, whether the claim is derived from the device’s intended use, indications for use, specification, or characteristic. Keep an inventory of all claims published about your device across your labeling library, from sales sheets to websites to social media posts.

Keeping track of website changes can be tricky. One way to do this is to maintain a library of screenshots whenever a change is made online that involves claims. Check out the Wayback Machine for doing this. Your web team might have another way to automatically capture and store versions of web pages but you would still need to track specific change dates in order for this to be a viable tracking method.

Ready to Learn More?

Managing device claims in a digital world is daunting but don’t let it hold you back from confidently promoting your device. If you need help determining what claims you can safely make about your product and where, our in-depth class on US and EU medical device labeling requirements is a great place to start. You’ll leave with a deep understanding of how to craft compelling but lawful claims about your device, how to manage claims in the digital space, train your teams, and establish a process for documenting claims.