The 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.
“Let me be clear. The FDA has no room for bad actors. Once we discover data integrity issues, we will respond accordingly,” 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 General Correspondence Letters were sent to 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.
“The FDA is committed to working with the medical device industry to remain vigilant in protecting the public health, including proactive practices in ensuring the data that sponsors include in medical device submissions are truthful and accurate,” said CDRH Director Michelle Tarver, M.D., Ph.D. “Until the two firms have adequately addressed these issues, all study data from all studies conducted at these testing facilities will be rejected.”
Accurate study data in a premarket submission is essential so that the FDA has the ability to fully and properly assess the overall safety and effectiveness of a device. Data that are copied from the results of another study, or are otherwise falsified or invalid, raise concerns about the reliability and validity of associated premarket submissions, which could ultimately put the public health at risk. Medical device sponsors contract with third-party companies to conduct performance, biocompatibility, and other product tests. The resulting data are included in marketing submissions to the FDA. However, unreliable data cannot be used to support the agency’s authorization decision.
The General Correspondence Letters are the latest step taken by the FDA to address concerns around testing data and the broader issue surrounding the integrity of data coming from foreign countries.
In September 2024, the FDA sent Mid-Link and SDWH warning letters citing both for laboratory oversight failures and animal care violations that raised concerns about the quality and integrity of data generated by the labs.
Last year, the FDA alerted the medical device industry to concerns regarding data from third-party testing labs, including those based in China, and stressed the need for firms to carefully review any data from testing that the firm itself did not perform.
Related Information
- FDA Issues Warning Letters to Two Chinese Firms Regarding Data Quality and Integrity Concerns, Violative Lab Practices | FDA
- Fraudulent and Unreliable Laboratory Testing Data in Premarket Submissions: FDA Reminds Medical Device Manufacturers to Scrutinize Third-Party-Generated Data | FDA
- Mid-Link General Correspondence Letter
- Sanitation & Environment Technology Institute of Soochow University Ltd. General Correspondence Letter