Draft: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices, Radiation-Emitting Products
Topics
Postmarket, Premarket, Real World Data / Real World Evidence (RWD/RWE)
Published
December 14, 2023
Last updated
February 7, 2024
Description
A draft guidance document on using real-world evidence to support regulatory decision-making for medical devices.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)