FDA admonishes Chinese device testing lab for falsified studies, copied data

The US Food and Drug Administration (FDA) on Monday published a letter to Chinese medical device testing firm Mid-Link Technology Testing advising the company that all data from its studies will be rejected until the company can adequately address its issues.

The letter, dated 26 February 2025, follows an earlier unpublished general correspondence letter dated 30 December 2024 and a warning letter sent to Mid-Link in September 2024. In a statement announcing the warning letter to Mid-Link and another Chinese firm, Sanitation & Environmental Technology Institute, Owen Faris, who then served as acting director of the Office of Product Evaluation and Quality within the Center for Devices and Radiological Health, reminded medical device makers of their responsibility for all the data they submit to the agency.

“FDA will take action to protect patients, consumers and the medical device supply chain from quality failures and violative practices. We strenuously remind industry of their responsibility and accountability for all data included in their submissions, which are required to comply with federal law,” Faris said.

Prior to the two warning letters, FDA had cautioned industry about a growing trend of “fraudulent and unreliable” third-party laboratory test data appearing in premarket submissions, including from labs in China and India. “This alarming trend has resulted in the FDA being unable to reach a substantial equivalence determination or otherwise authorize marketing for medical devices whose submissions include such data,” FDA wrote at the time.

Now, the agency said it has released its correspondence with Mid-Link, noting that the company has, in multiple instances, copied the results of other studies or created falsified or invalid data.

“As described in the December 30, 2024, GCL, FDA identified multiple test reports from studies conducted at your testing facility that have raised concerns, including cytotoxicity studies that contain identical or nearly identical results from different dates, sensitization studies (Guinea Pig Maximization Tests) that contain identical sets of guinea pig pretreatment body weights for different groups on different dates, and a large animal safety and performance study for a staple line reinforcement device that contains implausible bleeding assessments and pre-to-post-procedure weight gains in Bama pigs,” FDA wrote, adding that it is “highly improbably” these data and results were genuine.

While Mid-Link replied to FDA’s December 2024 letter, the agency said its response does not adequately address the issues it identified at the firm. FDA noted that the company committed to assess the root causes of the “apparently unreliable data” and look into why its quality assurance controls did not catch these issues. The company also said it would conduct an investigation of its entire operation to look for other instances of unreliable data, consult with third-party experts to address the issues raised in the warning letter, conduct a comprehensive review of its corrective and preventive actions (CAPAs), and to hire a qualified third-party expert to perform a gap assessment of the firm’s handling of good laboratory practice (GLP) data.

However, FDA said this response fails to fully address its concerns and that the company has not “provided a complete response that addresses any of the five items requested” in the December 2024 letter.

Letter

FDA admonishes Chinese device testing lab for falsified studies, copied data

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