Patient Engagement in the Design and Conduct of Medical Device Clinical Studies: Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
Information
Type
Guidance
Regulated products
Biologics, Medical Devices
Topics
Good Clinical Practice (GCP), Premarket
Published
January 26, 2022
Last updated
January 25, 2022
Description
This document provides guidance on involving patients in the design and execution of medical device clinical studies.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)