FDA Warns Of Device Testing Data Fraud, Will Not Accept Data From Chinese Company

FDA’s device center is warning manufacturers about unreliable third-party data on medical device effectiveness and safety generated by testing firms and says it will reject studies from a Chinese firm that has falsified data. “The FDA has noted an increase in unreliable testing data generated by third-party testing facilities on behalf of device manufacturers and sponsors,” the Center for Devices and Radiological Health (CDRH) said in a recent statement. “This has resulted in the FDA being unable to reach a...