MedTech manufacturers can find themselves behind the compliance eight ball during facility inspections performed by the Food and Drug Administration (FDA) if they fail to determine whether modifications made to medical devices over time are radically changing the products to the point of needing new marketing clearance, an investigator with the US agency says.
Problems with pre-market authorizations is “something that we still see problems with in the field. It’s a common topic in warning letters and [compliance] actions,” said Katelyn Staub-Zamperini, a senior operations officer in the FDA’s Office of Medical Device and Radiological Health Inspectorate (OMDRHI), within the agency’s Office of Inspections and Investigations (OII).
“What I’ve seen in the field is … a lack of a trigger for a review,” she said. Such a review would assist a manufacturer in determining whether a new pre-market authorization should be sought from the FDA.
“For example, there can be a change made to software, and the software engineers don’t have a trigger set up in their change system to communicate with regulatory folks to see if that change would require a review – and software updates in particular are a common cause,” she said.
At an “investigator insights” panel at MedCon 2025, Staub-Zamperini pointed out that software updates are a common cause of deficiencies noted during inspections.
“Software changes are often simply titled ‘updates,’ ‘upgrades,’ ‘improvements,’ and even ‘bug fixes’ by the software engineers. Those engineers are focused on fixing that bug and once the bug is fixed, their goal has been accomplished,” she said. “So, I’ve seen that lack of trigger with the regulatory staff to see if that software bug change … would have required a review.”
Staub-Zamperini went on: “If the changes you’ve made to your devices impact their use, safety, and effectiveness, at least review whether a new pre-market authorization should be performed. And depending on the review, if you’re not submitting for a new pre-market authorization, the only thing I can recommend is to justify, document, and really concrete that decision so whenever we come in, you can explain why.
“If the changes you make are changing the device’s functionality or user interface – those types of things – it really should be a careful consideration.”
Beware Design Creep
When a company makes a series of changes to a product over a long stretch of time, those modifications can add up and inadvertently trigger a need for a new FDA authorization.
“I’ve seen cases recently where a … pre-market application is over 15 years old, and over time, [the company] made small, little adjustments, and then looking now 15 years later, their product is nowhere near what it was originally because of all those little changes,” Staub-Zamperini said. “So, design creep over time can be an issue.”
Manufacturers are further reminded that they should document all changes, whether they’re incremental or all at once, in the change control section of their quality system.
‘Problematic’ Social Media Posts
A problem “we see quite often,” investigator Staub-Zamperini said, is when companies market a medical device beyond its authorized intended use – and social media is making the issue even more challenging for not only industry, but the FDA as well.
“A big thing that has become an issue recently is reviews on social media. As much as we’d all like to think that when we’re looking at reviews online, that they’re unbiased and we’re seeing the good, the bad, and ugly,” those reviews can be manipulated, she said. “If someone is posting a review that you’re able to remove, and it goes beyond your device’s intended use statement – if they’re saying it cured or treated something that your device is not cleared to say and you have the ability to remove that [review], then you should remove it.”
Adding to online marketing troubles are companies that use social media influencers to push product. When firms tell people to advertise on their behalf, that’s considered to be marketing and labeling by the FDA.
At the MedCon panel, fellow OMDRHI senior operations officer Mary Millner told manufacturers that they need to have a process in place to control and curb online language that can land them in hot water.
Millner explained that she recently inspected a company that had conversations with FDA staff regarding marketing information on their website that was outside the intended use of the product that the firm was manufacturing.
“In response to those conversations, the manufacturer did clean up the content on their website, but during my inspection, both during pre-inspection review and while I was on-site, I was coming across different social media posts that that were problematic,” Millner said.
“Now, these were not the older posts from before, when conversations were had with the FDA; it was some newer content,” she said. “The marketing team was posting things, but the regulatory team did not have any say into what was being posted, so they didn’t have the insight over their social media.”
In the end, the MedTech company wound up with a warning letter.
“The social media content was part of that warning letter,” Millner said. “So be aware that this is something we look at and it could be something that could end up in a warning letter.”
[Editor’s Note: Sifting through social media posts can be a royal pain and ensuring design changes don’t creep up on the medical device your company manufactures can both be daunting tasks – but QualityHub is here to help. Discover what QualityHub’s trusted quality and compliance consultants, project managers, and regulatory experts can do for you at qualityhub.com.]
