FDA expands data integrity crackdown to second Chinese lab

The U.S. Food and Drug Administration (FDA) has announced rejection of all study data to be submitted by a second Chinese-based medical device-testing laboratory from here on, saying the lab has created falsified or otherwise invalid data and copied results from another study in previous submissions to the FDA.

The action extends a broader agency crackdown on unreliable third-party medical device-testing data, which the FDA says is undermining the safety and regulatory evaluation of medical technologies intended for the US market.

In an email sent to members of the press—including this publication—on May 22, the FDA disclosed that it will no longer accept any study data from the Sanitation & Environment Technology Institute of Soochow University, which operates under the name SDWH.

“The FDA is vigilant in ensuring data submitted to the FDA can be relied upon to assess the effectiveness, safety, or risk of a device,” the FDA’s email we received as a member of the press says at the start. “The FDA has noted an increase in unreliable testing data generated by third-party testing facilities on behalf of device manufacturers and sponsors.”

“Based on data analysis, the FDA determined that Sanitation & Environment Technology Institute of Soochow University dba SDWH has, in several instances, copied the results of another study or created falsified or otherwise invalid data that was submitted to the FDA. Until the firm adequately addresses these issues, all study data from all studies conducted at this testing facility will be rejected.”

This announcement follows a similar determination made in March, regarding Mid-Link Technology Testing Co., Ltd., a separate Chinese-based testing provider. As with SDWH, all data from studies conducted at Mid-Link were announced to be categorically rejected unless the firm took adequate corrective actions.

The agency emphasized in the email that inaccurate or manipulated test data has prevented it from making substantial equivalence determinations—assessments necessary for authorizing the marketing of medical devices. In addition to delaying regulatory decisions, such data problems risk slowing patient access to legitimate innovations and disrupting supply chains.

In its latest public update, the FDA revised its website’s Notifications on Data Integrity – Medical Devices webpage to include the new warning related to SDWH. The site now features General Correspondence Letters issued to both SDWH and Mid-Link and reminds manufacturers and sponsors to critically evaluate any third-party labs they use for safety, performance and cybersecurity testing. The agency urges firms to independently verify all test results prior to submission.

The FDA reiterated its commitment to taking enforcement actions where needed, noting that data integrity remains fundamental to its mission of ensuring the safety and effectiveness of medical devices in the United States.

Featured photo shows FDA Laboratory Building 62 (Engineering and Physics), which houses the Center for Devices and Radiological Health. Source: FDA Bldg 62 – Exterior. Photo by: The U.S. Food and Drug Administration. Public domain image.