US FDA issues action plan for AI and machine learning-based software as medical device

The US Food and Drug Administration (FDA) issued a discussion paper titled Proposed Regulatory Framework for Modifications to Artificial Intelligence (AI) / Machine Learning (ML)–Based Software as a Medical Device (SaMD). It noted that the traditional paradigm of medical device regulation was not designed for adaptive AI/ML technologies, which have the potential to adapt and optimise device performance in real time. These tools require a new regulatory approach that enables a rapid cycle of product improvement while providing effective safeguards. The proposed framework is based on the International Medical Device Regulators Forum (IMDRF) risk categorisation principles, the FDA’s benefit-risk framework, and more. The proposed framework seeks early input from groups and individuals outside the agency. The proposed approach aims to assure that ongoing algorithm changes are implemented accordingly with pre-specified performance objectives and include real time monitoring of performance. The approach aims to promote a mechanism for manufacturers to be vigilant in maintaining the safety and effectiveness of their SaMD products.