US Regulatory Considerations for Low Field Magnetic Resonance Imaging Systems
Open accessAbstract
Although there has been a resurgence of interest in low field magnetic resonance imaging (MRI) systems in recent years, low field MRI is not a new concept. FDA has a long history of evaluating the safety and effectiveness of MRI systems encompassing a wide range of field strengths. Many systems seeking marketing authorization today include new technological features (such as artificial intelligence), but this does not fundamentally change the regulatory paradigm for MR systems. In this review, we discuss some of the US regulatory considerations for low field magnetic resonance imaging (MRI) systems, including applicability of existing laws and regulations and how the U.S. Food and Drug Administration (FDA) evaluates low field MRI systems for market authorization. We also discuss regulatory considerations in the review of low field MRI systems incorporating novel AI technology. We foresee that MRI systems of all field strengths intended for general diagnostic use will continue to be evaluated for marketing clearance by the metric of substantial equivalence set forth in the premarket notification pathway.
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User characteristics, interface design, and the environment of use can influence safety and effectiveness.
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From Toward Safer Diagnoses: A SEIPS-Based Narrative Review of Diagnostic Errors (2026) · cites this paper as [327]
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- Authors
- Krainak, D. M., Zeng, R., Li, N., Woods, T. O., & Delfino, J. G.
- Affiliations
- United States Food and Drug Administration (US)
- Corresponding author
- Delfino, Jana Gut
- Venue
- Magnetic Resonance Materials in Physics, Biology and Medicine
- Published
- 2023-05-16
- Volume
- 36
- Issue
- 3
- Pages
- 347-354
- ISSN
- 0968-5243 (ISSN-L)
- 1352-8661
- PMC
- PMC10386952
- OpenAlex
- W4376642284
- Cited by
- 5
- References
- 6
- Citations by year
- 2026: 1 · 2025: 1 · 2023: 3
- FWCI
- 0.20
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- Magnetic Resonance Materials in Physics Biology and Medicine (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Advanced MRI Techniques and Applications
- Health Sciences › Health Professions › Medical Laboratory Technology › Quality and Safety in Healthcare
- Keywords
- low-field MRI, substantial equivalence, premarket notification, artificial intelligence in medical devices
- MeSH terms
- Artificial Intelligence, Magnetic Resonance Imaging, United States, United States Food and Drug Administration
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