Medical Device Advertising Regulations: What to Know

What if we told you that there aren’t any medical device advertising regulations? Would that surprise you? After all, healthcare advertising is notoriously riddled with strict rules and regulations that make running impactful campaigns a tedious and time-consuming process.
Well, you’re in for a surprise. Right now, medical device advertising doesn’t come with a ton of red tape — at least not as much as you’d think, giving you more freedom and flexibility than some of your contemporaries.
Let us explain.

Can You Advertise Medical Devices Online?

Yes. There’s nothing stopping you from advertising medical devices online. The only caveat is that the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have some control over restricted and non-restricted medical devices, respectively. In general, though, advertising medical devices comes with far fewer rules and regulations than other healthcare companies, namely, those in pharma.
That said, under no circumstances can you advertise or promote experimental or investigational medical devices, nor can you promote an “off-label” usage, i.e., an intended use other than that in the proposed labeling.

What’s a Restricted Medical Device?

The FDA defines a restricted medical device as one that “can only be sold on oral or written authorization by a licensed practitioner or under conditions specified by regulation.” For example, pacemakers and hearing aids are restricted medical devices. Devices outside of this definition are considered “non-restricted,” which collectively make up the majority of the medical device market — a market that generated more than $412.4 billion in 2020.1

Who Regulates Medical Device Advertising?

In the United States, the FDA is authorized to regulate the advertising of restricted medical devices; the FTC regulates everything else. These governing bodies can review labeling and other publicly disseminated materials, including digital ads.

Medical Device Advertising Regulations: What Do They Actually Mean?

You can navigate FDA and FTC medical device ad regulations by asking yourself this question: Does the FDA consider the device “restricted” based on its pre-market approval? In other words, does your device do what the FDA approved it to do?
For example, hearing aids are intended to “help people with or compensating for, impaired hearing.” Anything that falls outside of this definition would be considered “off-label.”
The FDA also has statutory authority to regulate your ads and promotions. However, how deep its authority goes isn’t abundantly clear. The Federal Food, Drug, and Cosmetic Act (FDCA) has only two provisions regarding advertising of restricted medical devices:
  • A restricted device is misbranded if its advertising is false and misleading in any particular way.
  • A restricted device is misbranded if its advertising does not contain a brief statement of the device’s intended use and relevant warnings, precautions, side effects, and contraindications.
What does this mean? From a high level, as long as you accurately advertise and promote your medical devices in accordance with what the FDA approved them for, you’ll be fine.
Ad regulations are similar for non-restricted devices. The only difference is that the FTC has authority. But again, few formal regulations exist.

Medical Device Advertising Regulations From Facebook & Google

While there aren’t many regulations from the FDA and FTC, many advertising platforms, like Facebook and Google, have other restrictions you should pay attention to. Here’s what you need to know.

Facebook

While Facebook doesn’t allow medical device companies to use their commerce channels, healthcare marketers can advertise most medical products (unsafe supplements prescription drugs are prohibited), provided they follow a few rules:
  • Ad content shouldn’t contribute to negative self-perception, such as highlighting a specific body type as desirable.
  • Ads should never draw attention to health conditions, such as zoomed-in images of bacne.
  • Ads shouldn’t contain false, deceptive, or misleading claims.
  • Ads that include debunked claims related to medical treatments are prohibited.

Google

Google also has a variety of policies related to medical device advertising. Here are several you should know:
  • Marketers cannot promote non-government approved medical products that are advertised in a way that implies they’re safe and effective in treating a particular disease or ailment.
  • It’s prohibited to market products that have been subject to any government or regulatory warning.
  • Promotion of experimental medical treatments is prohibited.
  • Clinical trial recruitment is prohibited in many countries. However, it is allowed in Canada, the United States, and some other countries.
  • It’s prohibited to promote at-home HIV tests except in the U.S., France, the Netherlands, and the U.K.
  • Ads related to fertility and birth control are prohibited in some countries, such as Iran, China, and Saudi Arabia.

Medical Device Advertising Regulations: Adfire Health’s Advice

“Are there specific medical device ad regulations we should follow?”
We get this question often from our medical device clients. And rightfully so. You’d think there would be a long list of medical device ad regulations from the FDA and FTC. But there really isn’t one. That said, while you do have fewer guardrails, don’t go rogue. Following medical device advertising best practices is still in your best interest.

Focus on the Details

The old adage “it’s all in the details” applies here. Although fewer boundaries may make you think you have to work quickly, try not to. Take your time, perfect your messaging and creatives, and build smart audiences based on your campaign’s goals and objectives.
Not only will focusing on the details during campaign creation improve overall performance, but it’ll almost certainly help you catch any red flags the FDA or FTC may see — for example, not including a brief statement of the device’s intended use and relevant warnings, precautions, side effects, and contraindications.

Be Consistent Across All Channels

It’s almost a given that you’ll need campaigns with ads running across multiple digital devices and channels. Why? Because the average person has access to more than 10 connected devices, the same devices on which the medical device industry runs.2 The reliance on technology will continue as the greater healthcare industry adopts all things digital to improve HCP-patient outcomes.
Due to this complexity, it’s important to maintain consistency and ensure that your ads are compliant with FDA and FTC regulations. For smaller teams, maintaining consistency is relatively simple, but for larger teams working cross-functionally, it can get tricky.
To help, consider creating a set of agreed-upon guidelines that everyone can reference to make sure all parts of your campaigns are meeting FDA and FTC medical device advertising regulations. Likewise, you may find it helpful to “perfect” one ad and then simply version it for each ecosystem, i.e., mobile vs. display.

Pay Attention

Succeeding in the medical device industry is often about looking forward and identifying opportunities to be the first mover. When it comes to maintaining FDA and FTC medical device ad compliance, you can find value in looking in the rear-view mirror. Specifically, by looking at what your competitors are doing and whether the FDA or FTC is sounding the alarm. If they do, take note of their misstep.

You should also keep tabs on news and announcements from the FDA and FTC. Just because they haven’t instituted or enforced strict regulations, doesn’t mean they won’t do so in the future.
If you keep these best practices in mind and stay apprised of any changes to medical device advertising and promotion regulations, you’ll be in good shape.

Sources

  1. Astute Analytica. Medical Devices Market Size Worth USD 625.3 Billion by 2027 | CAGR: 6.3%: Astute Analytica. Cision US Inc. Published October 20, 2021. Accessed January 19, 2022.
  2. Lionel Sujay Vailshery. Average number of connected devices residents have access to in U.S. households in 2020, by device. Statista. Published March 2020. Accessed January 19, 2022.