Today, May 22, 2025, “[t]he U.S. Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) issued General Correspondence Letters to two third-party testing companies in China after discovering data that was falsified or otherwise found to be invalid” (see the FDA announcement here).  The two labs receiving the so-called General Correspondence Letters are identified as Mid-Link Technology Testing Co., Ltd. (“Mid-Link”) in Tianjin, China, and Sanitation & Environment Technology Institute of Soochow University Ltd. (dba “SDWH”) in Suzhou, China.

“The letters stated in part, that because the FDA could not ensure the reliability and validity of biocompatibility testing and animal safety and performance testing studies conducted at their respective testing facilities, the agency will reject those testing facilities’ data generated for use in premarket device submissions.”  In addition, the FDA said that until the firms have provided sufficient evidence that they have resolved their data integrity issues, the Agency will reject all data from those testing facilities in support of device filings.

The notice does not indicate what action the FDA will take about data that has been generated in support of devices already approved or cleared, if applicable.  The FDA has consistently warned sponsors of drug and device filings that they are responsible for ensuring the reliability of data submitted in their filings that are generated by third-party testing facilities.  The FDA goes on to say that “[u]ntil the two firms have adequately addressed these issues, all study data from all studies conducted at these testing facilities will be rejected.”

Similar data integrity issues have been found in third-party data submitted by contract research organizations (CRO) for inclusion in drug applications at the Center for Drug Evaluation and Research (CDER).  In such instances, the FDA has required either repetition of the questionable studies at different CROs or justification of the reliability of clinical and/or bioequivalence testing results submitted to the FDA prior to and/or after approval.

The FDA notice linked above also contains the following historical information relative to the ongoing investigation of these two laboratories:

  • FDA Issues Warning Letters to Two Chinese Firms Regarding Data Quality and Integrity Concerns, Violative Lab Practices | FDA (here)
  • Fraudulent and Unreliable Laboratory Testing Data in Premarket Submissions: FDA Reminds Medical Device Manufacturers to Scrutinize Third-Party-Generated Data | FDA (here)
  • Mid-Link General Correspondence Letter (here)
  • SDWH General Correspondence Letter (here)
  • Notifications on Data Integrity – Medical Devices | FDA (here).

Please read these documents as they provide the FDA’s current thinking on data integrity issues and the actions the Agency may take if DI issues are found.