JAMA Network December 7, 2021
Regulators in Canada and the UK have worked with FDA officials to identify guiding principles for using machine learning technologies in medical device development.
Machine learning uses software algorithms that can improve performance automatically through real-world use. However, these technologies “present unique considerations due to their complexity and the iterative and data-driven nature of their development,” Bakul Patel, MSc, MBA, director of the FDA’s Digital Health Center of Excellence, said in a statement.
Together, the 3 countries identified 10 principles that are intended to lay the foundation for developing safe, effective, and high-quality medical devices that use artificial intelligence and machine learning. They...
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