Evaluation of Sex-Specific Data in Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Good Clinical Practice (GCP), Premarket
Published
August 22, 2014
Last updated
March 2, 2020
Description
This document is a guidance document titled "Evaluation of Sex-Specific Data in Medical Device Clinical Studies" for the FDA and industry staff. It covers topics such as Good Clinical Practice and Premarket.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)