Design Considerations for Pivotal Clinical Investigations for Medical Devices: Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA Staff
Information
Type
Guidance
Regulated products
Biologics, Medical Devices
Topics
Good Clinical Practice (GCP), Investigational Device Exemption (IDE), Premarket
Published
November 7, 2013
Last updated
August 10, 2023
Description
This document provides guidance on pivotal clinical investigations for medical devices, covering topics like GCP, IDE, and premarket considerations.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)