Roughly a year ago, the US Food and Drug Administration (FDA) said in a safety communication that testing performed at dozens of sponsor-hired third-party labs uncovered fraudulent and unreliable test results meant to be used for pre-market submissions bound for the agency’s product reviewers – a wake-up call for scores of manufacturers and a reminder for them to highly scrutinize data outputs from third parties.
After that discovery, the FDA’s Center for Devices and Radiological Health used pre- and post-market surveillance data, along with data and information generated by CDRH’s compliance and enforcement activities, to address widespread problems with data integrity in the MedTech industry. That’s when the agency made public more information that found increasing instances of fraudulent and unreliable data in product submissions and data developed by third-party test labs, including two in China, which received FDA warning letters.
One of those warning letters addressed, among other things, biocompatibility in animal studies, noting that “study data was reporting identical or nearly identical results across different studies conducted on different dates, supporting different submission types, and [the FDA] also saw some improbable data trends based on the information that was submitted, where it was inconsistent with normal physiology, or what you would expect from the animal based on the testing that was that was done. So, this essentially calls into question all data that was generated by the lab,” said Sean Boyd, VP of Orlando, FL-based QualityHub, a consultancy for the medical device and pharmaceutical industries.
The FDA’s device center notified that Chinese lab in a February General Correspondence Letter that the agency – which considers data integrity a lynchpin for ensuring that devices are safe, effective, and of high quality – would not accept any of that lab’s data until corrections were made.
“The result is, [the FDA doesn’t] have any confidence in this particular lab’s ability to produce reliable data,” Boyd said. “[This concern] is reflected potentially in industry submissions, and there are certainly downstream impacts on this as well as we look at other potential submissions that are impacted that may have already had a market authorization decision made. Going forward for this particular lab, [the agency isn’t going to accept] any data that has been performed by this lab for purposes of evaluating market authorization.”
Boyd – who until recently was director of the Office of Regulatory Programs within CDRH’s Office of Product Evaluation and Quality (OPEQ) – made his comments at an April 23 session at MedCon 2025 in Columbus, Ohio.
“It’s really important [for medical device manufacturers] to consider carefully which labs they work with and evaluate the processes they have in place to verify that the information that is being supplied to them on their behalf that is going to be submitted in a market authorization document is reliable and valid, and that the agency can trust that [data] in making its market authorization decisions,” he said.
Boyd pointed out that the FDA “wants technology to be available to patients” and doesn’t want the operations of the agency or MedTech companies to be disrupted. Nevertheless, he is concerned that these data integrity issues are just the “tip of the iceberg.”
“There is a lot of discussion ongoing right now within the device center on how to address a retrospective evaluation of [data integrity] impacts [involving problematic third-party labs], as well as a forward-looking evaluation of how [the agency] will prevent and address this going forward,” he said. An FDA “policy on the retrospective look is in the process of being developed, and [the agency is] looking at what authorities it has to deal with the issue, and to work with sponsors, and what options are available. But I don’t know what that answer will ultimately be.”
At the same MedCon session, Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), said device makers must “kick the tires” of third parties to make sure they’re in good standing when it comes to data integrity.
“It may be that [your company doesn’t] even directly contract with one of these two [Chinese labs that received FDA warning letters], but perhaps you’re using a third party that does – and [that third party’s] lack of accountability for this has been astounding,” Leahey said. “So just noting a flag there – when you’re doing diligence, make sure you kick the tires on who they are, utilizing these folks in the past, and what process they had or didn’t have that would have let this problem kind of slip into the cracks.”
QualityHub’s Boyd added that manufacturers should pay close attention to FDA websites as they pertain to data integrity, including those specific to medical devices.
“This is information that would fall within the critical safety communications that the agency hopefully is able to continue to update in real time and is not delayed,” Boyd said. “But CDRH does intend to share all information with industry as it becomes available. So, keep an eye on who the center is looking at, what actions are being taken against specific labs, and stay on top of this going forward.”
