WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has issued General Correspondence Letters to two third-party testing companies in China after uncovering falsified or otherwise invalid data. The action represents a firm response to data integrity breaches that could undermine medical device safety and disrupt the global supply chain.
The letters, sent to Mid-Link Technology Testing Co., Ltd. in Tianjin and Sanitation & Environment Technology Institute of Soochow University Ltd. (dba “SDWH”) in Suzhou, state that the FDA cannot ensure the reliability of biocompatibility and safety testing data generated by these facilities. Consequently, the agency will reject any data from these labs used in premarket submissions for medical devices.
“Let me be clear. The FDA has no room for bad actors,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Such false and shoddy activity jeopardizes access to new devices for patients and healthcare providers, negatively impacts product sponsors, and potentially disrupts the medical device supply chain.”
The agency’s action follows prior concerns raised in September 2024, when both companies were cited in warning letters for laboratory oversight failures and animal care violations. These earlier issues cast doubt on the quality and integrity of data produced at their facilities.
CDRH Director Michelle Tarver, M.D., Ph.D., emphasized the FDA’s commitment to ensuring data accuracy in submissions, saying, “Until the two firms have adequately addressed these issues, all study data from all studies conducted at these testing facilities will be rejected.”
Falsified or invalid test results can have serious public health implications by preventing the FDA from accurately assessing the safety and effectiveness of medical devices. The industry often relies on third-party labs for testing, but the FDA is urging firms to scrutinize data from external sources to prevent a reliance on unreliable findings.
The FDA has issued repeated warnings about the growing problem of data integrity violations, particularly at foreign testing facilities. Last year, the agency called on device sponsors to adopt more stringent evaluations of outsourced testing data.
This latest enforcement highlights the FDA’s ongoing efforts to uphold data integrity and protect public health, ensuring that medical devices brought to market meet rigorous safety and effectiveness standards.
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