Singapore HSA: SaMD Regulation Guidelines Feedback

Singapore HSA: SaMD Regulation Guidelines Feedback

Singapore’s Health Sciences Authority (HSA) is seeking feedback on draft guidelines released on standalone medical mobile applications and qualification of clinical decision support software (CDSS). Based on the International Medical Device Regulators Forum’s (IMDRF)...
FDA Releases AI/ML Five-Part Action Plan for SaMD

FDA Releases AI/ML Five-Part Action Plan for SaMD

The U.S. Food and Drug Administration (FDA) released its artificial intelligence/machine learning five-part action plan for software as a medical device (SaMD). The FDA announced in the plan its intention to create a tailored regulatory framework for SaMD, as well as...