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Notification on Data Integrity
The FDA is vigilant in ensuring that data submitted to the FDA can be relied upon to assess the effectiveness, safety, or risk of a device. The Agency continues to observe unreliable testing data generated by third-party testing facilities on behalf of device manufacturers and sponsors.
Based on data analyses, the FDA has determined that CCIC Huatongwei International Inspection (Suzhou) Co., Ltd. has, in several instances, copied the results of another study or created falsified or otherwise invalid data that were 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, please contact the Division of Industry and Consumer Education.
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