FDA Rejects Data from Two Chinese Testing Labs Over Integrity Concerns

The U.S. Food and Drug Administration (FDA) has disqualified testing data from two Chinese laboratories, citing concerns about data falsification and validity issues that could compromise the safety of medical devices entering the U.S. market. The move marks a significant enforcement action as the FDA continues to scrutinize the reliability of foreign-generated clinical and laboratory testing data.

General Correspondence Letters were issued by the FDA’s Center for Devices and Radiological Health (CDRH) to Mid-Link Technology Testing Co., Ltd., based in Tianjin, and Sanitation & Environment Technology Institute of Soochow University Ltd. (operating as SDWH), based in Suzhou. The agency stated it will no longer accept biocompatibility and animal safety data produced by these firms in support of premarket medical device submissions. This decision follows an internal review that found manipulated or otherwise unreliable data in studies from both labs.

The FDA emphasized that the exclusion of data from these companies is necessary to uphold public health standards. As third-party labs often play a central role in generating evidence used to evaluate the safety and effectiveness of medical devices, the integrity of their data is critical. The agency reiterated that any findings of falsified or invalid information not only jeopardize public safety but also pose significant risks to the supply chain and could delay access to vital medical products.

This latest enforcement action builds on previous steps taken by the agency. In September 2024, the FDA issued warning letters to both Mid-Link and SDWH, citing deficiencies in laboratory oversight and violations in animal care protocols. These deficiencies were deemed significant enough to question the reliability of their generated data. Additionally, the FDA has previously cautioned the industry to thoroughly vet data from third-party labs, especially those based abroad, in light of ongoing concerns about testing integrity.

Article by multiple RFHC contributors, based upon information from the U.S. Food and Drug Administration press release.

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