Today, the U.S. Food and Drug Administration (FDA) issued this final guidance: Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment. This guidance document provides the FDA’s recommendations on testing to assess the safety and compatibility of medical devices in the MR Environment and the recommended format for Magnetic Resonance Imaging (MRI) Safety Information in medical device labeling. Ensuring the safety of patients who use magnetic resonance imaging (MRI) for disease diagnosis and health management is vital.
Facts about the final guidance
This final guidance:
- Provides recommended format to clarify and simplify labeling for magnetic resonance imaging (MRI) safety information consistent with FDA-recognized consensus standards.
- Applies to all medical devices that might be used in the MR environment, including all implanted medical devices and all medical devices that are fastened to or carried by a patient (such as, external insulin pump or pulse oximeter). Note: the guidance does not apply to the MR system or accessories, such as MR coils and positioning pads.
- Provides recommendations on MR safety and compatibility assessments and labeling information that should be included in premarket submissions.
Upcoming webinar on this guidance
On June 24, 2021, the FDA will host a webinar for industry and others interested in learning more about the guidance.