The U.S. Food and Drug Administration (FDA) has issued a draft guidance on assessing the safety of medical devices intended for use in areas where devices employing magnetic resonance (MR) magnets are present.
Issued in early August, the draft guidance, entitled “Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment,” provides recommendations on MR safety and compatibility assessments that should be included in FDA premarket submissions for devices such as implantable medical devices and external devices that are attached to or carried by a patient, as well as devices that may be used within an MR environment. The draft guidance also includes information on the recommended formatting of safety information for MRI devices, consistent with medical device labeling requirements.
Once approved in final form, the draft guidance will supersede the FDA’s 2014 Guidance “Establishing Safety of Passive Implants in the Magnetic Resonance (MR) Environment.”
Guidance documents issued by the FDA and other federal agencies do not have the force of law and are intended only to provide interested parties with the current thinking of regulators on topics of interest.