Essentials of Software as a Medical Device & Clinical Decision Support Systems

Describes key definitions associated ​with SaMD and CDSS, when a software platform ​is SaMD or when it is considered CDSS, and the regulatory framework ​for research with SaMD and CDSS.

Recommended Use: Required
ID (Language): 21583 (English)
Author(s): Tamiko Eto, MS, CIP - Mayo Clinic; Jonathan Green, MD, MBA - National Institutes of Health

Explains how identifiable and deidentified data in ​non-interventional investigational device studies ​are processed and how the design of software functions can ​impact investigational device determinations. It also describes combination device, device import, and ​device sharing considerations as well as sponsor-investigator requirements ​and responsibilities.

Recommended Use: Required
ID (Language): 21584 (English)
Author(s): Tamiko Eto, MS, CIP - Mayo Clinic; Jonathan Green, MD, MBA - National Institutes of Health

Describes when AI/ML-enabled medical devices ​are considered SaMD, the regulation of AI/ML-enabled medical devices, the application of Good Machine ​Learning Practices (GMLPs), and the potential research related ​harms associated with AI/ML.

Recommended Use: Required
ID (Language): 21585 (English)
Author(s): Sunny Chung, MD, MHS - Yale School of Medicine; Dennis L. Shung, MD, MHS, PhD - Yale School of Medicine

Discusses the phases of SaMD and CDSS development; how to assess the readiness level in ​SaMD and CDSS; and how to prepare for continued monitoring, reporting, and modifications to approved/cleared SaMD and CDSS.​ It also examines other key regulations, standards, best practices, and tools for SaMD and CDSS design, development, implementation, and deployment.

Recommended Use: Required
ID (Language): 21586 (English)
Author(s): Sunny Chung, MD, MHS - Yale School of Medicine; Dennis L. Shung, MD, MHS, PhD - Yale School of Medicine