August 08, 2019

FDA Releases Draft Guidance on Safety in the MR Environment

On August 2, 2019, the Food and Drug Administration (FDA) announced the availability of the draft guidance for industry and FDA staff, ‘Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.’ Stakeholder comments are requested by October 1.

The draft guidance provides recommendations on assessments of the safety and compatibility of medical devices in the MR environment and the format for magnetic resonance imaging (MRI) safety information in medical device labeling. The purpose is to aid the consistency of reviews, testing and MRI safety labeling across a variety of medical devices and to adequately mitigate the unique safety hazards presented by certain devices in or near the MR system.

Various American College of Radiology (ACR) commissions, committees and staff are reviewing the draft guidance. Members interested in contributing feedback for potential future ACR comments should contact Michael Peters, ACR director of legislative and regulatory affairs, at (202) 223-1670 or mpeters@acr.org.