Notifications on Data Integrity – Medical Devices
The FDA’s Center for Devices and Radiological Health (CDRH) 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. In addition to obvious negative impacts to sponsors, these adverse determinations caused by unreliable testing data may also delay or reduce access to new devices that the FDA ultimately authorizes for patients and health care providers and increase the potential for disruption in the supply chains for devices.
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.
FDA has Issued the Following Letters on Data Integrity
- General Correspondence Letter Issued to Mid-Link Technology Testing Co., Ltd.
- The FDA determined that Mid-Link Technology Testing Co., Ltd., 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.