Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Biologics, Medical Devices, Radiation-Emitting Products
Topics
Clinical - Medical, Good Clinical Practice (GCP), Investigational Device Exemption (IDE), Labeling, Microbiology, Pediatric Product Development, Premarket
Published
September 12, 2017
Last updated
April 8, 2024
Description
This document is a guidance document titled "Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies" for the industry and FDA staff. It covers topics such as clinical studies, good clinical practice, labeling, and premarket evaluation.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)