February 21, 2024

FDA issues warning on fraudulent, unreliable medical device testing data

Editor's Note

The FDA has issued a warning regarding fraudulent, duplicated and otherwise unreliable data coming from third party test labs that produce data for medical device companies, including many based in India and China. Issued February 20, the alert warns medical device manufacturers that they are responsible for confirming the accuracy of third-party data. 

The agency notes that an uptick in false data in recent years is impacting its ability to authorize marketing for affected devices. Unreliable data also limits access and disrupts supply chains. “Device firms need to be diligent in order for this to stop,” the alert reads.

The agency further advises manufacturers to take proactive steps to verify third-party test lab data in an FDA submission—especially data related to biocompatibility and other performance testing, included in their FDA submission. Manufacturers also can partner with third-party labs that have been accredited under the Accreditation Scheme for Conformity Assessment (ASCA) program, although the report emphasizes that independent assessment of all third-party data is still essential.

The agency acknowledges that firms may not be able to identify data that has been copied. However, the agency emphasizes that “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."    

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