The US Food and Drug Administration (FDA), Health Canada, and the UK Medicines and Healthcare products Regulatory Agency (MHRA) have released additional guiding principles for machine learning-enabled medical devices (MLMDs) that focus on transparency of information for stakeholders that interact with the device.
“The underlying objectives of these guiding principles are to foster international harmonization and to underscore the importance of considering transparency throughout the life cycle of MLMDs,” Troy Tazbaz, director of the Digital Health Center of Excellence at FDA’s Center for Devices and Radiological Health, stated in a news release…
