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Applying Real-World Device Data: US FDA Finalizes Its Thoughts

 
• By David Filmore

The agency issued a final guidance spelling out reasonable applications of real-world device evidence and what factors must be considered when weighing whether data collected from routine care via means – such as electronic patient records or insurance claims – can help support a product approval or other regulatory decision.

Real-world device data may be suitable to support clearance or approval of a new device or expanded indication, but controls to mitigate bias and ensure data is sufficiently relevant and reliable are a must, US FDA conveys in a final guidance posted Aug. 30.

The final "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices" tracks very closely to a draft version issued in July 2016, but it includes some more explicit statements supporting application of real-world evidence (RWE) as a regulatory tool, particularly in support of pre-market submissions

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