Regulatory considerations for medical imaging AI/ML devices in the United States: concepts and challenges

Nicholas A. Petrick; Weijie Chen; Jana G. Delfino; Brandon D. Gallas; Yanna Kang; Daniel Krainak; Berkman Sahiner; Ravi K. Samala

doi:10.1117/1.JMI.10.5.051804

23 June 2023 Regulatory considerations for medical imaging AI/ML devices in the United States: concepts and challenges

Nicholas A. Petrick, Weijie Chen, Jana G. Delfino, Brandon D. Gallas, Yanna Kang, Daniel Krainak, Berkman Sahiner, Ravi K. Samala

Author Affiliations +

Journal of Medical Imaging, Vol. 10, Issue 5, 051804 (June 2023). https://doi.org/10.1117/1.JMI.10.5.051804

Abstract

Purpose

To introduce developers to medical device regulatory processes and data considerations in artificial intelligence and machine learning (AI/ML) device submissions and to discuss ongoing AI/ML-related regulatory challenges and activities.

Approach

AI/ML technologies are being used in an increasing number of medical imaging devices, and the fast evolution of these technologies presents novel regulatory challenges. We provide AI/ML developers with an introduction to U.S. Food and Drug Administration (FDA) regulatory concepts, processes, and fundamental assessments for a wide range of medical imaging AI/ML device types.

Results

The device type for an AI/ML device and appropriate premarket regulatory pathway is based on the level of risk associated with the device and informed by both its technological characteristics and intended use. AI/ML device submissions contain a wide array of information and testing to facilitate the review process with the model description, data, nonclinical testing, and multi-reader multi-case testing being critical aspects of the AI/ML device review process for many AI/ML device submissions. The agency is also involved in AI/ML-related activities that support guidance document development, good machine learning practice development, AI/ML transparency, AI/ML regulatory research, and real-world performance assessment.

Conclusion

FDA’s AI/ML regulatory and scientific efforts support the joint goals of ensuring patients have access to safe and effective AI/ML devices over the entire device lifecycle and stimulating medical AI/ML innovation.

CC BY: © The Authors. Published by SPIE under a Creative Commons Attribution 4.0 International License. Distribution or reproduction of this work in whole or in part requires full attribution of the original publication, including its DOI.

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Nicholas A. Petrick, Weijie Chen, Jana G. Delfino, Brandon D. Gallas, Yanna Kang, Daniel Krainak, Berkman Sahiner, and Ravi K. Samala "Regulatory considerations for medical imaging AI/ML devices in the United States: concepts and challenges," Journal of Medical Imaging 10(5), 051804 (23 June 2023). https://doi.org/10.1117/1.JMI.10.5.051804

Received: 2 February 2023; Accepted: 30 May 2023; Published: 23 June 2023

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