Regulatory considerations for medical imaging AI/ML devices in the United States: concepts and challenges.
J Med Imaging (Bellingham)
; 10(5): 051804, 2023 Sep.
Article
em En
| MEDLINE
| ID: mdl-37361549
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.
Texto completo:
1
Base de dados:
MEDLINE
Tipo de estudo:
Guideline
/
Prognostic_studies
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article