Content of Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport and Storage of Organs for Transplantation - Guidance for Industry and FDA Reviewers
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Investigational Device Exemption (IDE), Premarket
Published
January 15, 2001
Last updated
March 19, 2020
Description
This document is a guidance for industry and FDA reviewers on Investigational Device Exemptions for organ transplantation solutions.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)