FDA Issues Draft Guidance on the Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

Today, the U.S. Food and Drug Administration released a draft guidance document on the Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. This draft guidance clarifies how the FDA determines that real-world data may be sufficient for use in premarket and postmarket regulatory decisions, without changing the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 prospectively collect and use real-world data for purposes of determining the safety and effectiveness of a device.

Real-world data, which are collected from sources outside of traditional clinical trials, can provide powerful insight into the benefits and risks of medical devices, including how they are used by health care providers and patients.  The draft guidance gives generalized examples taken from actual uses of real-world data as valid scientific evidence for various regulatory decisions.

This draft guidance is a cornerstone of our strategic priority of creating a national evaluation system for medical devices.  That system would build on and leverage the vast amount of data and information collected during the treatment and management of patients.

We welcome comments regarding this draft guidance. The notice of availability will be published in the Federal Register on 7/27/16, and the docket for receiving comments will be open for 90 days from that date.

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, 301-796-7100 or dice@fda.hhs.gov.

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