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FDA Warns Device Manufacturers About Fraudulent Third-Party Performance Testing


NEW YORK – The US Food and Drug Administration on Tuesday issued a letter to medical device manufacturers and sponsors of device studies warning them to independently verify performance test results before submitting them to the agency due to concerns about fraudulent results. 

The agency noted that it has seen an increasing number of third-party test laboratories, including many based in China and India, generate data that is fabricated, duplicated from other device submissions, or otherwise unreliable. The trend "has resulted in the FDA being unable to reach a substantial equivalence determination or otherwise authorize marketing for medical devices whose submissions include such data," it said.

The FDA added that it is "incumbent on device firms to take proactive steps to qualify third-party test labs" and closely evaluate all testing data that a firm doesn't gather itself, particularly data related to biocompatibility and other performance testing, that is included in an FDA submission. While it can be difficult for individual firms to know if some data has been copied from an unrelated marketing submission, the FDA said it expects device firms to identify testing results that are improbable, impossible, or do not seem consistent with known information about the device.

The agency said it is pursuing various actions to identify and confront data integrity violations, including through its Bioresearch Monitoring Program but noted that it is also calling upon the medical device industry to be "vigilant and proactive about ensuring the integrity of all data they include in medical device submissions." The Bioresearch Monitoring Program encompasses on-site inspections, data audits, and remote regulatory assessments to monitor all aspects of the conduct and reporting of FDA-regulated research.