Manufacturers of MRI scanners
MRI scanners are both radiation-emitting electronic products and medical devices subject to the requirements of the Food, Drug, and Cosmetic Act.
- As medical devices, MRI scanners are subject to the general controls of the Act, such as device registration and listing, premarket notification, maintenance of records and reports, and good manufacturing practices. The FDA takes a risk-based approach to medical device regulation, and MRI scanners are Class II (moderate risk) medical devices, meaning that an MRI manufacturer is required to submit a Premarket Notification 510(k) prior to marketing their MRI System.
- As radiation-emitting electronic products, MRI scanners are subject to the general requirements of the Electronic Product Radiation Control provisions of the Act, such as maintenance of records and reports, notification of defects, repurchase, repair, or replacement, and importation.
You may find additional useful information on FDA’s website on Overview of Medical Device Regulation.
FDA Guidance Documents relevant to MRI scanners
- Guidance for Industry: Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices
- Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 78KB)
Standards Relevant to MRI scanners
The following are FDA recognized voluntary consensus standards relevant to MRI scanners.
- IEC 60601-2-33 - Medical Electrical equipment – Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
- NEMA MS 1 - Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Images
- NEMA MS 2 - Determination of Two-dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
- NEMA MS 3 - Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
- NEMA MS 4 - Acoustic Noise Measurement Procedure for Diagnostic Magnetic Resonance Imaging Devices
- NEMA MS 5 - Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging
- NEMA MS 6 - Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel, Non-Volume Coils in Diagnostic Magnetic Resonance Imaging (MRI)
- NEMA MS 8 - Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems
- NEMA MS 9 - Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images
- NEMA MS 10 - Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging Systems
- NEMA MS 12 - Quantification and Mapping of Geometric Distortion for Special Applications
Manufacturers of devices intended to enter the MR environment
The MR environment presents unique safety hazards for patients with implanted and accessory medical devices.
- The strong, static magnetic field of the MRI scanner induces displacement forces and torques on magnetic materials that may cause unwanted movement of a device.
- The radiofrequency energy and magnetic fields that change with time may cause heating of the device and the surrounding tissue.
- The magnetic fields and radiofrequency energy produced by an MRI scanner may also cause electrically active medical devices to malfunction and may induce voltages in leads or other long conductive portions of the medical device, which can result in a failure of the device to deliver the intended therapy.
- The presence of the device will degrade the quality of the MR image and may make the MR scan uninformative or may lead to an inaccurate clinical diagnosis, potentially resulting in inappropriate medical treatment.
You should consider all of the above hazards when evaluating the safety of your device in the MR environment. For additional guidance, please refer to FDA’s guidance document, Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment.
FDA Guidance Documents relevant to MRI safety
- Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment - Guidance for Industry and Food and Drug Administration Staff (PDF - 224KB)
- Assessment of Radiofrequency- Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices
Standards Relevant to MRI safety
The following are FDA recognized voluntary consensus standards relevant to the safety of medical devices in the MR environment.
- ASTM F2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment.
- ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants.
- ASTM F2182 Standard Test Method for Measurement of Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging
- ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
- ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
- ISO TS 10974 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device