FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: USE OF REAL-WORLD EVIDENCE TO SUPPORT REGULATORY DECISION-MAKING FOR MEDICAL DEVICES; GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF; AVAILABILITY

WASHINGTON, Dec. 18 -- Food and Drug Administration has issued a notice called: Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability.

The notice was published in the Federal Register on Dec. 18 by Lowell M. Zeta, Acting Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance entitled "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices." FDA is issuing this guidance to clarify how FDA evaluates real-world data (RWD) to determine whether they are of sufficient quality f...