Dive Brief:

• The Food and Drug Administration has found Mid-Link Technology Testing copied the results of another study or created falsified or otherwise invalid data.
• Officials published their accusations Tuesday, releasing a letter that claims the Chinese service provider generated “highly improbable” cytotoxicity datasets that contained “identical or nearly identical results.”
• FDA inspectors found multiple animals gained exactly the same weight in Mid-Link tests, leading to a warning letter last year. The FDA said Mid-Link has failed to adequately address its concerns and, as such, the agency will reject all data from all studies run by the company.

Dive Insight:

The FDA published a warning in February 2024 about an “alarming” rise in the inclusion of “testing data that are fabricated, duplicated from other device submissions or otherwise unreliable” in premarket submissions. FDA inspectors visited Mid-Link’s facility in Tianjin, China, one week after the agency shared the warning. 

Inspectors found many animals gained exactly 0.5g in a study, something Mid-Link study directors agreed was impossible. The FDA sent a warning letter covering the weight-gain claim and other accusations in September. 

On Tuesday, the FDA revealed it sent a General Correspondence Letter (CGL) to Mid-Link in December. The letter outlined the agency’s concerns with the weight-gain data, “implausible bleeding assessments” and other problems with Mid-Link’s cytotoxicity and sensitization studies. The service provider responded to the letter in January but failed to convince the FDA of the reliability of its data.

The FDA said Mid-Link’s response lacked an explanation of why its facility failed to identify and assess the anomalies or how its processes and procedures allowed multiple studies to generate anomalous data. Mid-Link did not provide information on whether other studies have similar anomalies, the FDA said, and offered no reason why the anomalous results should not raise questions about the validity of all its data. 

“Put simply, because you have been responsible for the copying of results of another study or creation of falsified or otherwise invalid data that was submitted to FDA in the studies discussed in the GCL, we have no reason to believe that any data that you have produced are reliable,” the FDA said.

That conclusion led the FDA to decide to reject all study data from all studies conducted at Mid-Link until the company has demonstrated that it has adequately addressed the issues described in the CGL. The FDA declined Mid-Link’s request for a meeting because the company “has not substantively responded to the concerns” it laid out in December.

The FDA wrote that accurate study data is needed to properly assess whether patients or users are safe when exposed to a device, citing concerns like allergic reactions, fever, toxicity that leads to loss of tissue/organ function or failure and anaphylaxis, a life-threatening allergic reaction.

“These adverse health effects represent a clear risk to patients and clinical practitioners,” the agency stated.