Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff

Information

Type

Guidance

Regulated products

Medical Devices, Radiation-Emitting Products

Topics

Premarket

Published

October 10, 2023

Last updated

October 10, 2023

Description

This document provides guidance for the submission of premarket notifications for magnetic resonance diagnostic devices.

Organization

Country / Region

United States

License

Other (Public Domain)

Feedback

Suggest an improvement to this page

Actions

Social networks

Embed