SaMD
A category of software product under the FDA regulatory framework, referring to software systems intended for medical diagnosis, treatment, or clinical decision support. Such software is subject to medical device regulations and must meet applicable compliance requirements governing safety and effectiveness.
Core Facts
Timeline (last 90 days)
If real-time voice AI involves triage recommendations or medication prompts, it may touch on the regulatory boundaries of medical device software (SaMD) and clinical decision support.
The U.S. FDA has established a dedicated Digital Health Center of Excellence (DHCoE) to conduct pre-market review of AI/ML software as a medical device (SaMD).
All Facts (3)
The FDA has a clear regulatory framework for AI-assisted medical decision-making tools, classifying them as Software as a Medical Device (SaMD).
90%UnverifiedIf real-time voice AI involves triage recommendations or medication prompts, it may touch on the regulatory boundaries of medical device software (SaMD) and clinical decision support.
50%UnverifiedThe U.S. FDA has established a dedicated Digital Health Center of Excellence (DHCoE) to conduct pre-market review of AI/ML software as a medical device (SaMD).
50%