The FDA determined that the company has submitted copied, falsified, or otherwise invalid data in submissions to the agency.
Key Takeaways:
- FDA Rejects Mid-Link Data – The agency will not accept study results from Mid-Link Technology Testing Co, Ltd, until issues are adequately addressed due to findings of copied, falsified, or invalid data.
- Warning to Manufacturers – The FDA urges medical device sponsors to scrutinize third-party testing labs and independently verify submitted data.
- Regulatory Integrity Concerns – The FDA states it remains focused on addressing data reliability issues to ensure the safety and effectiveness of medical devices.
The US Food and Drug Administration (FDA) published a General Correspondence Letter issued to Mid-Link Technology Testing Co, Ltd, after determining that the company submitted copied, falsified, or otherwise invalid data in submissions to the agency.
As a result, the agency will reject all study data from the firm—which provides medical device and pharmaceutical regulatory consulting and testing services—until it “adequately addresses” these issues.
“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 from certain third-party testing labs. 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 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,” the FDA states.
The agency further notes that “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.”
The FDA reminds sponsors of device studies and manufacturers of devices 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 notes in the letter that it “remains committed to taking appropriate actions to address ongoing data integrity concerns.”
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