See how FDA enforces labeling and advertising rules through real cases—from off-label promotion to social media misbranding—and learn key lessons to avoid warnings, recalls, or penalties in your own device marketing practices.
Examining case studies of FDA enforcement can provide valuable insights into what can go wrong and how to prevent it. Below are a few notable examples where device companies faced regulatory action due to labeling or advertising non-compliance:
A medical device firm marketed a diagnostic device that had been cleared only as an adjunctive screening tool, implying in promotional materials that it could be used as a standalone diagnostic test. In other words, the FDA-cleared use was to supplement standard diagnostics, but the company’s brochures and website suggested their device was sufficient by itself. What happened? The FDA issued a Warning Letter to the company, stating that the advertising was misbranding the device by suggesting an unapproved use. The agency noted that the promotional claims “implied that the device could be used as a standalone test,” which had never been evaluated or cleared. The firm was required to immediately cease those claims and put out corrected information. This case underscores how even an implication or subtle shift in wording can cross the line – the company didn’t outright say “for standalone use,” but the FDA picked up on the suggestion and acted.
A startup developed a skincare laser device that they believed was similar enough to existing products that it didn’t need a 510(k) clearance (they treated it as 510(k)-exempt). They began selling it and even featured customer testimonials on their website calling the product “revolutionary” and “FDA approved.” What happened? During an inspection, FDA reviewers saw the website and determined that the device actually had significant technological differences requiring a 510(k), and certainly had never been “approved.” The FDA issued a Warning Letter citing that the device was being sold without the required premarket clearance or approval, making it an adulterated device, and that the claims of “FDA Approved” were false and misleading – a clear misbranding. The combination of no clearance and false claims led to a stern enforcement action. The company had to halt marketing and go back to seek proper 510(k) clearance, and of course scrub any “FDA approved” language. This case shows that overzealous marketing (using “FDA approved” improperly) and bypassing regulatory pathways can be catastrophic – it’s a reminder that if your device is not actually approved or cleared, you cannot legally market it at all, much less brag that FDA has endorsed it.
In some instances, enforcement comes in the form of recalls rather than letters. A hypothetical example: A company sells a Class II infusion pump and labels it as suitable for “all ages” and “delivering any liquid medication.” However, it later emerges that the pump had not been tested or cleared for certain critical drugs and had a risk of dosing errors in neonates. FDA might push the company to issue a voluntary recall (Class I, the most serious) to correct the labeling, because it was overly broad and omitted important limitations, thus posing a significant health risk. The recall notice would detail that the prior labeling was incorrect and new labeling will restrict the device’s use. This kind of enforcement (though voluntary) is still public and serious, and often comes with FDA oversight.
A recent trend involves FDA reviewing companies’ social media. For example, a device firm posted an Instagram image touting their implant’s success rate without mentioning any risks or that it’s only indicated for a specific condition. FDA’s Ad Promotion surveillance team (in CDRH) could send an Untitled Letter (a step below a warning letter) saying that the Instagram post misbranded the device by failing to disclose important information and by implying use in a broader patient population. The company in a known case had to take down the post and institute a social media training program for staff. This illustrates that FDA’s eyes are on digital communications too, not just formal labeling.
Between 2018 and 2022, the FDA took 255 enforcement actions related to medical device advertising issues. These actions range from warning letters and untitled letters to more drastic measures. In especially severe cases, the Department of Justice may get involved, resulting in consent decrees or fines. For example, while many device firms haven’t yet seen pharma-sized fines, the DOJ has settled with some device companies over off-label promotion in the multi-million dollar range, and executives can face individual consequences (criminal charges under the FD&C Act’s misbranding provisions, which can mean fines or even jail for intentional violations). The increasing number of actions signals that regulators are actively policing device marketing. FDA also sometimes publicizes these actions via press releases, which can be damaging to a company’s reputation.
The case studies above teach a few clear lessons. First, never assume that promotional language “flies under the radar.” Even implications or omissions can be caught. It’s safer to be abundantly clear and conservative in your claims. Second, don’t market before you’re legally allowed to. If you lack clearance for a use, no marketing that suggests that use – period. Third, monitor and audit your own marketing regularly. Pretend you’re an FDA inspector and look at your website, your brochures, your social media – would anything raise a question? Doing this periodically can catch issues before FDA does. Lastly, if you do receive an FDA warning or untitled letter, respond promptly and thoroughly, and take corrective action across all media. FDA often looks at whether a company’s response shows understanding and a plan to fix systemic issues.
For companies operating globally, note that other regulators (like the European authorities) also watch for misleading promotion, but FDA’s enforcement tends to be among the most stringent. Thus, aligning your practices to FDA’s expectations usually sets a good baseline for compliance elsewhere too.
By studying these enforcement cases, medical device firms can better appreciate the importance of compliant labeling and advertising. It’s much preferable to invest in compliance up front than to deal with the fallout of an FDA enforcement action later. As a final piece, we will discuss aligning global labeling to U.S. requirements – which is another area where companies often stumble when entering the U.S. market.
