PROPOSED REGULATORY FRAMEWORK FOR MODIFICATIONS TO ARTIFICIAL INTELLIGENCE/MACHINE LEARNING (AI/ML)- BASED SOFTWARE AS A MEDICAL DEVICE (SAMD) IN US

Computer systems can learn and adapt by implementing human intelligence, which is known as artificial intelligence (AI).When it used in combination with medical software, it creates an artificial intelligence (AI)-based medical device that uses in data and algorithms to help with activities like diagnosis and treatment suggestions, potentially increasing the accuracy and effectiveness of medical care, and the use of Artificial Intelligence/Machine Learning (AI/ML) into medical devices, especially Software as a Medical Device (SaMD), this enclosed important concepts like AI/ML, medical devices, SaMD, 510(k) notifications, FDA, CDRH, PMA, TPLC, IMDRF, SPS, and ACP.Through launch the issues raised by AI/ML in SaMD, the structure required to strike a compromise between patient safety and innovation.The subject is to establish the SaMD Pre-Specifications (SPS) and Algorithm Change Protocol (ACP) as crucial elements for open changes, ongoing monitoring, and post-market surveillance.Primary goal is to extend the framework by providing guidance for change control plans using AI/ML methods, particularly those with software learning over time.The Premarket