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