Citing Data Integrity Concerns, FDA Warns Device Study Sponsors About Fraudulent Lab Testing

Dennis Tosh
February 29, 2024 at 11:56 AM EST
In a Feb. 20 letter to the medical device industry, the FDA warned device sponsors of an increase in fabricated or otherwise unreliable laboratory test data being provided by third-party test labs and then forwarded to the agency in marketing submissions. The FDA said that it was “reminding sponsors of device studies and manufacturers of devices to carefully evaluate the thir... Read More

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