FDA CDRH provides comprehensive FAQs addressing regulatory classification and oversight of clinical decision support software (CDSS). The guidance clarifies distinctions between software qualifying as a medical device under FDA jurisdiction versus informational tools falling outside regulatory scope. Key topics include risk assessment methodologies, software development and validation requirements aligned with IEC 62304 standards, cybersecurity considerations, and clinical effectiveness evaluation. This reference document serves as essential regulatory interpretation for manufacturers developing CDSS and healthcare IT professionals navigating FDA's evolving software oversight framework.

FDA CDRH provides regulatory guidance for artificial intelligence-enabled medical devices, addressing the unique oversight considerations for AI/machine learning-based Software as a Medical Device (SaMD). The resource covers quality management systems, validation methodologies, performance monitoring, and cybersecurity requirements aligned with IEC 62304 standards. It serves as a reference document for manufacturers developing AI-integrated medical devices authorized for U.S. marketing, emphasizing transparency, safety evaluation, and ongoing post-market surveillance protocols.

The FDA has updated its comprehensive searchable databases of medical devices incorporating digital health technologies authorized for U.S. marketing. These updated lists encompass artificial intelligence and machine learning-enabled devices, augmented and virtual reality medical devices, and sensor-based digital health technology solutions. This resource provides manufacturers, healthcare professionals, and regulatory stakeholders transparent access to cleared and approved AI/digital health-integrated medical devices, supporting informed decision-making and regulatory compliance efforts while facilitating continued innovation in the digital health medical device sector.

Final guidance clarifying the regulatory status of Clinical Decision Support (CDS) software under Section 520(o) of the FD&C Act. Defines criteria distinguishing device CDS (subject to FDA oversight) from non-device CDS (exempt). Addresses application to AI/ML-based CDS functions and provides examples across clinical specialties.