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Notification of Data Integrity
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 has noted an increase in unreliable testing data generated by third-party testing facilities on behalf of device manufacturers and sponsors. This has resulted in the FDA being unable to reach a substantial equivalence determination or otherwise authorize marketing for medical devices whose submissions rely on such data.
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.
Sponsors of device studies and manufacturers of devices are reminded to carefully evaluate the third parties they engage to conduct safety, performance, and cybersecurity testing and to independently verify all testing results before submitting to the FDA.
The FDA remains committed to taking appropriate actions to address ongoing data integrity concerns.
Questions?
If you have questions, contact the Division of Industry and Consumer Education.
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