1. Artificial intelligence/machine learning (AI/ML)-Based software as a medical device (SaMD) action plan;U.S. Food and Drug Administration,2021
2. Marketing submission recommendations for a predetermined change control plan for artificial intelligence/machine learning (AI/ML)-Enabled device software functions;U.S. Food and Drug Administration,2023
3. Proposal for a regulation laying down harmonised rules on artificial intelligence;European Commission,2021
4. Software and artificial intelligence (AI) as a medical device;Medicines and Healthcare Products Regulatory Agency (UK),2023
5. Questions and answers on custom-made devices & considerations on adaptable medical devices and patient-matched medical devices;Medical Device Coordination Group,2021