US regulatory considerations for low field magnetic resonance imaging systems.

Journal: Magma (New York, N.Y.)
Published Date: May 16, 2023

Abstract

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.

Authors

  • Daniel Michael Krainak
    Division 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.
  • Rongping Zeng
    Center for Devices and Radiological Health, US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • Ningzhi Li
    Division 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.
  • Terry O'Riska Woods
    Standards and Conformity Assessment Program, Office of Strategic Partnership and Technology Innovation, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, 20993, USA.
  • Jana Gut Delfino
    Division of Imaging Diagnostics and Software Reliability, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, US Food and Drug Administration, 10903 New Hampshire Ave, Bldg 62, Silver Spring, MD, 20993, USA. Jana.Delfino@fda.hhs.gov.

Keywords

External Resources

Popular Topics
Recent Journals