Data Integrity Concerns: USFDA Issues Notification Citing Two Chinese Firms

The USFDA issued a notification on 22 May, 2025 on Data Integrity concerns on reliability and validity of biocompatibility testing and animal safety and performance testing studies conducted for Medical devices by third Party testing facilities. As per the notification “ FDA has noted an increase in unreliable testing data generated by third-party testing facilities on behalf of device manufacturers and sponsors”. FDA observed several instances of results copied from other studies or created falsified data submitted to FDA.

FDA issued General Correspondence Letters to third party testing firms:

• Mid-Link Technology Testing Co., Ltd. (“Mid-Link”) in Tianjin, China
• Sanitation & Environment Technology Institute of Soochow University Ltd. (dba “SDWH”) in Suzhou, China

In the letter issued to Mid-Link, FDA notes finding identical or nearly identical results from different dates in cytotoxicity studies, sensitization studies, large animal safety and performance studies. FDA observes that generating identical/nearly identical data for the different cytotoxicity and sensitization studies is highly improbable and concludes the results were copied from another study or were falsified. Similar observations were made in the letter issued to the other Third Party testing facility Sanitation & Environment Technology Institute.

FDA is advising sponsors of device studies to conduct safety, performance and cybersecurity testing and independently verify all testing results of third-party labs engaged for conducting the studies.

• FDA Notifications on Data Integrity – Medical Devices
• FDA News Release: FDA Takes Action to Address Data Integrity Concerns with Two Chinese Third-Party Testing Firms