The U.S. Food and Drug Administration (FDA) is advising medical device manufacturers to take steps to verify the accuracy and reliability of third-party testing data before submitting it to the FDA.
In a recent update to its website, the FDA says that the agency “has noted an increase in unreliable testing data generated by third-party testing facilities on behalf of device manufacturers and sponsors.”
As an example, the FDA cites a letter sent in late February to Mid-Link Technology Testing Company by the FDA’s Center for Devices and Radiological Health (CDRH). In that letter, the CDRH notifies Mid-Link that it has identified “several instances” in which the company “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,” the CDRH writes, “all study data from all studies conducted at this testing facility will be rejected.”
The FDA’s “Notifications on Data Integrity – Medical Devices” webpage is available at https://www.fda.gov/medical-devices/industry-medical-devices/notifications-data-integrity-medical-devices.
The CDRH’s letter to Mid-Link is available at https://www.fda.gov/media/185743/download?attachment.
