Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Investigational Device Exemption (IDE), Labeling, Premarket, Safety - Issues, Errors, And Problems
Published
March 22, 2016
Last updated
February 9, 2019
Description
This document provides guidance on assessing radiofrequency-induced heating in the MR environment for medical devices.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)