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The U.S. Food and Drug Administration (FDA) is reminding sponsors of device studies and manufacturers of devices to carefully evaluate the third parties they engage to conduct performance testing and to independently verify all testing results before submitting to the FDA.
The FDA has identified an increase in submissions containing unreliable data generated by third-party test labs, including from numerous such facilities based in China and India. This alarming 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.
To protect patients and healthcare providers from substandard products and ensure that U.S. patients have access to safe, effective, and high-quality medical devices, the FDA is pursuing various actions to identify and confront data integrity violations including through our Bioresearch Monitoring Program. At the same time, the FDA is calling upon the medical device industry to be vigilant and proactive about ensuring the integrity of all data they include in medical device submissions.
Questions?
If you have questions about third-party generated data, contact the Division of Industry and Consumer Education.
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