Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

Today, the U.S. Food and Drug Administration 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 whether real-world data may be sufficient for use in regulatory decisions, without changing the evidentiary standards we use to make those decisions.  It clarifies how we plan to evaluate real-world data to determine whether it may be sufficiently relevant and reliable for various regulatory decisions, and it also clarifies 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). 

On October 10, 2017 from 1:00-2:30pm EST, the FDA will hold a webinar about this guidance. Registration is not necessary.

• To hear the presentation and ask questions:
  Dial: 800-779-8625; passcode: 7388850 | International: 1-210-234-0098; passcode: 7388850
• To view the slide presentation during the webinar:
  https://www.mymeetings.com/nc/join.php?i=PWXW5328003&p=7388850&t=c

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

If you have general questions about this guidance, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041 or 301-796-7100 or dice@fda.hhs.gov.

Thank you,
Food and Drug Administration
Center for Devices and Radiological Health