The U.S. Food and Drug Administration (FDA) has issued new guidance on the use of real-world evidence in medical device development.
The document, titled "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices; Guidance for Industry and Food and Drug Administration Staff," is scheduled for publication in the Federal Register on August 31.
The guidance clarifies how the agency evaluates real-world data to determine whether standards for use in regulatory decisions are met. The guidance does not change the evidentiary standards that are required to make those decisions.
The FDA hopes to encourage the development and use of real-world evidence based on actual use by advancing these expanded recommendations for device manufacturers and the medical community, said FDA Commissioner Dr. Scott Gottlieb in a statement.
