Webinar Materials

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On Tuesday, October 10, 2017, from 1:00-2:30 PM EST, the FDA hosted a webinar for industry interested in learning more about the final guidance document “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.” This guidance is applicable to all devices, as that term is defined under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act); including software that meets the definition of a device. This guidance clarifies how the agency determines whether real-world data may be sufficient for use in regulatory decisions, without changing the evidentiary standards we use to make those decisions. It also clarifies how we plan to evaluate real-world data to determine whether it may be sufficiently relevant and reliable for various regulatory decisions, and when an Investigational Device Exemption (IDE) may be needed to collect and use real-world data for purposes of determining the safety and effectiveness of a device.

Real-world data, which relate to patient health status and/or the delivery of health care routinely collected from a variety of sources, can provide powerful insight into the benefits and risks of medical devices, including how they are used by health care providers and patients. This guidance is a cornerstone of our strategic priority to build a national evaluation system for health technology (NEST).

During this webinar, the FDA provided:

• An overview of real-world data and real-world evidence;
• Clarification about how the agency plans to evaluate real-world data to determine whether it may be sufficiently relevant and reliable for various regulatory decisions; and
• Clarification about when an Investigational Device Exemption (IDE) may be needed to collect and use real-world data for purposes of determining the safety and effectiveness of a device.

If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2014, 301-796-7100 or [email protected].