The Food and Drug Administration (FDA) issued a guidance document: Guidance for Industry and Food and Drug Administration Staff, which provides its 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 document applies to all medical devices that might be used in the MR environment. This includes all implanted medical devices, medical devices that are fastened to or carried by a patient (e.g., external insulin pump, pulse oximeter), medical devices that would reasonably be anticipated to enter the MR environment during clinical care, and all medical devices that are intended to enter the MR environment. The recommendations in this guidance for MR labeling of devices are consistent with ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.
The FDA-recognized consensus standards and guidance documents may be useful when assessing the safety of a medical device within the MR environment or developing MRI Safety Information for the medical device labeling. The listed documents are general or cross-cutting consensus standards or guidances that apply broadly to many medical devices. Consensus standards or guidance documents for specific medical devices may also include device-specific recommendations for MRI safety testing and labeling.
