MedCon: FDA officials review common medical device compliance pitfalls

COLUMBUS, OH – Lack of documentation for software changes, design creep, and marketing beyond authorized intended use are common issues US Food and Drug Administration (FDA) officials said they encounter during the premarketing review of medical devices.

While the vast majority of firms are largely compliant, these are common issues that often end up as the subject of warning letters and actions, a panel of agency officials told attendees at the 2025 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative.

“This is a topic that, to me, seems like it should be straightforward, but it is not, and it’s definitely something that we still see problems within the field,” Katelyn Staub-Zamperini, medical device senior operations officer in the Office of Medical Device and Radiological Health Inspectorate (OMDRHI) and Office of Inspections and Investigations (OII) at FDA, told attendees.

If a design change impacts a medical device’s use, safety, or effectiveness, it warrants at least a review of the device, Staub-Zamperini noted. “[D]epending on the review, if you’re not submitting the premarket authorization, the only thing I can recommend is justify, document, really concrete that decision, so whenever we come in, you can explain why,” she said.

Design creep

Changes that impact the functionality and user interface of a device should be a “careful consideration,” Staub-Zamperini explained. The “biggest issue stemming from this,” she said, comes when software engineers do not have a trigger in their change system to alert the regulatory team in a company when a change would warrant a review. For instance, changes to software requiring a review can sometimes be labeled as an upgrade, update, improvement, or a bug fix.

“I’ve seen at firms, their software engineers, they’re focused on fixing that bug, and once the bug is fixed, their goal has been accomplished,” Staub-Zamperini said. “I’ve seen that lack of a trigger, with the regulatory staff coming in to see if that’s the software bug, and [the] change that it made happen would have required a review.”

Another major issue surrounding premarket authorizations is a design brief that resembles the original submitted device, but not the current device on the market.

“I've seen cases recently where a design, their premarket authorization is over 15 years old,” Staub-Zamperini said. “Over time, they've made small little adjustments, and then looking now, 15 years later, their product is nowhere near what was originally cleared because of all these little changes.”

Marketing beyond authorized intended use

An “increasingly big issue” is companies marketing their devices beyond authorized intended use, including on social media, Staub-Zamperini told attendees.

“Social media, if your company controls it—it’s one thing if someone personally is posting on their own social media about products—but if the company controls social media, we look at that and we consider that labeling,” she said.

This also includes reviews being posted online by consumers making claims about a device that go beyond authorized intended use. If a company is capable of moderating reviews that are posted online, Staub-Zamperini explained, they should remove reviews that make these unauthorized claims.

“I’m not saying to remove all negative reviews,” she said. “I’m saying if someone is posting a review that you’re able to remove, and it goes beyond your intended use statement—if they’re saying this cured or treated something that your device is not cleared to say, and you have the ability to remove that, you should remove that.”

Staub-Zamperini said she has seen companies use and give instructions to social media influencers to promote their medical devices, and said this counts as marketing and labeling as well. “[I]f your firm has control over what you are telling people to advertise on your behalf, that is marketing, that is labeling,” she said. “[W]e are looking at that.”

LCDR Mary Millner, senior operations officer in OMDRHI and OII at FDA, said there needs to be a process within companies of controlling, reviewing, and improving social media content as with other labeling. “The process might look a little different, but this is something that, really, it needs to be controlled,” she said.

FDA has warned companies in the past for posts the marketing team at a company made on social media without consulting the regulatory team, Millner said.

“I just want to make you aware this is something that we look at and definitely could be something that could end up in a warning letter,” she said.

MedCon: FDA officials review common medical device compliance pitfalls

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