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FDA Will Use Real-World Evidence in Regulatory Decision-Making for Medical Devices

This week, the Food and Drug Administration (FDA) released a final guidance document on the Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. This guidance clarifies how the agency determines if real-world data, which is data derived from sets of patients in real-life practice setting (i.e., insurance claims or electronic health records), may be sufficient for use in regulatory decisions, such as determining the safety and effectiveness of a device.

The FDA will hold a webinar about this guidance on Tuesday, October 10, 2017, from 1:00 to 2:30 p.m.

More information about this webinar or our complete webinar series can be found on the Medical Device Webinars and Stakeholder Calls webpage