FDA’s Action Plan for AI/ML-based Software as a Medical Device (SaMD)
In recent times, the use of AI/ML (Artificial Intelligence/Machine Learning) has taken a huge technological sweep in the medical devices and healthcare industries because of their ability to diagnose, manage and treat a wide variety of medical conditions and to enhance the patient care. But there seem to be obstacles in implementing AI/ML in daily practices, with respect to the transparency issues surrounding their software programs. Hence, it is crucial to regulate these technologies and to do so, the Regulatory bodies are effortlessly trying hard to govern the AI/ML implementation.