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US regulatory considerations for low field magnetic resonance imaging systems
Daniel Michael Krainak1, Rongping Zeng2, Ningzhi Li1
1Division of Radiological Imaging and Radiation Therapy Devices, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, 20993, USA.
Magma (New York, N.Y.)
|May 16, 2023
Summary
Low field magnetic resonance imaging (MRI) systems are being re-evaluated by the U.S. Food and Drug Administration (FDA). The FDA uses existing regulations and the substantial equivalence metric for market authorization, even with AI integration.
Area of Science:
- Medical Imaging Technology
- Regulatory Science
Background:
- Low field magnetic resonance imaging (MRI) systems are experiencing renewed interest.
- The U.S. Food and Drug Administration (FDA) has a long-standing history of regulating MRI systems across various field strengths.
Purpose of the Study:
- To review US regulatory considerations for low field MRI systems.
- To discuss the FDA's evaluation process for low field MRI systems, including those with artificial intelligence (AI).
Main Methods:
- Review of existing US laws and regulations applicable to MRI systems.
- Analysis of FDA's premarket notification pathway and the substantial equivalence metric.
Main Results:
- Existing regulatory frameworks are applicable to low field MRI systems.
- Novel technologies like AI do not fundamentally alter the regulatory paradigm for MRI systems.
Conclusions:
- Low field MRI systems, including those with AI, are evaluated under established FDA regulatory pathways.
- General diagnostic MRI systems, regardless of field strength, will likely continue to be cleared via the premarket notification pathway based on substantial equivalence.
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