Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Premarket

Published

June 19, 2014

Last updated

March 24, 2020

Description

This document is a guidance for industry and FDA staff on criteria for significant risk investigations of magnetic resonance diagnostic devices.

Organization

Country / Region

United States

License

Other (Public Domain)

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