The FDA has been approving AI/ML-enabled medical devices for nearly 30 years, including over 600 devices to date, primarily in radiology but also in other specialties like cardiovascular and neurology. These devices undergo the same regulatory pathways and oversight as other medical devices, assessing factors like safety, effectiveness, data quality, and clinical performance. Collaboration among regulatory bodies has led to guiding principles for Good Machine Learning Practice (GMLP) and the use of predetermined change control plans (PCCPs) to manage device changes. AI in medical devices aims to support clinicians, improve patient care, and enhance healthcare efficiency, with efforts ongoing to standardize terms and definitions in the field.

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