Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment

Guidance for Industry and Food and Drug Administration Staff

Introduction
This guidance document provides Food and Drug Administration’s (FDA’s or the Agency’s) recommendations on testing to assess the safety and compatibility of medical devices in the Magnetic Resonance (MR) Environment and the recommended format for Magnetic Resonance Imaging (MRI) Safety Information in medical device labeling. This guidance supersedes FDA’s Guidance entitled “Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment,” dated December 11, 2014. Throughout this guidance, the terms “FDA,” “the Agency,” “we,” and “us” refer to the Food and Drug Administration and the terms “you” and “yours” refer to medical device manufacturers.

For the current edition of the FDA-recognized standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database. ¹ For more information regarding use of consensus standards in regulatory submissions, please refer to the FDA guidance titled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.”

The contents of this document do not have the force and effect of law and are not meant to bind. the public in any way, unless specifically incorporated into a contract. This document is intended. only to provide clarity to the public regarding existing requirements under the law. FDA. guidance documents, including this guidance, should be viewed only as recommendations, unless. specific regulatory or statutory requirements are cited. The use of the word should in Agency. guidance means that something is suggested or recommended, but not required.