FDA Issues Guidance on Real-World Evidence

The FDA finalized guidance on the use of real-world evidence to support the agency’s regulatory decisions on medical devices.

The agency will use the new criteria outlined in the guidance to determine whether real-world data meet its quality standards for decision-making, safety surveillance, and supplementing information gathered during clinical trials. More specifically, the agency may use real-world data for evaluating biomarkers, new indications, and de novo classification requests, among other potential uses.

Sponsors planning to collect real-world data from a device that is not being used in the normal course of medical practice may be required to obtain an investigational device exemption, the agency said.