Third-party test labs are increasingly generating false results for medical device studies, and manufacturers are responsible for validating the data, the FDA said Feb. 20.
Medical device companies should "carefully evaluate the third parties" they use for performance tests submitted to the FDA, the agency said. In recent years, there has been an uptick in unreliable data, including fabricated information and duplicated results from other device submissions.
The fake data not only affects the device's chance for approval but can hinder patient access to new devices.
"We acknowledge it may be difficult for individual device firms to know if certain data have been copied from an unrelated marketing submission, but we expect device firms to identify testing results that are improbable or impossible on their face or do not seem consistent with known information about the device," the agency said.
Numerous facilities in China and India are fabricating medical device data, according to the FDA, which did not specify the labs.