Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices : Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Adverse Event Reporting, Antimicrobial Resistance, Biostatistics, Microbiology, Postmarket, Real World Data / Real World Evidence (RWD/RWE)
Published
August 31, 2017
Last updated
June 26, 2023
Description
This document is a guidance for using real-world evidence to support regulatory decisions for medical devices.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)