The Association for the Advancement of Medical Instrumentation (AAMI) has published an article on the lag in regulatory legislation or guidance for medical devices and systems that use artificial intelligence (AI) and machine learning (ML).
Manufactures and regulators in this space must use existing regulations, standards, and guidance when designing, developing, testing, releasing, distributing, and maintaining AI/ML-enabled medical devices. The article outlines considerations for manufacturers that allows them to effectively leverage existing medical device regulations. It also includes a fictitious case study to demonstrate the use of existing standards and regulations for new technology.
“Using Existing Regulatory Frameworks to Apply Effective Design Controls to AI/ML in Medical Devices” is available on AAMI’s website.