The U.S. Food and Drug Administration (FDA) is raising concerns about the integrity of data submitted by two China-based testing laboratories in support of recent premarket medical device submissions.
Detailed in a press release, the FDA’s Center for Devices and Radiological Health (CDRH) has issued General Correspondence Letters to Mid-Link Technology Testing Company, based in Tianjin, China, and the Sanitation & Environment Technology Institute of Soochow University in Suzhou, China. The FDA’s communications inform the testing laboratories that it has been unable to “ensure the reliability and validity of biocompatibility testing and animal safety and performance testing studies” conducted at their respective laboratories.
As a result, the CDRH says that it will reject data generated by those two testing laboratories for use in premarket device submissions “until the two firms have adequately addressed these issues.”
The FDA has previously raised concerns about the operations of these two testing laboratories. In a September 2024 warning letters send to each laboratory, the FDA identified “laboratory oversight failures and animal care violations” that raised questions about the quality and integrity of data generated by the testing laboratories.
The FDA’s press release detailing its actions in connection with two China-based testing companies is available at https://www.fda.gov/news-events/press-announcements/fda-takes-action-address-data-integrity-concerns-two-chinese-third-party-testing-firms
