SaMD Definitions.pdf

Software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.
Medical Purpose: Diagnosis, prevention, monitoring, treatment, or alleviation of disease.
Medical Device: Any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
In Vitro Diagnostic (IVD) Medical Device: Reagents, calibrators, control materials, kit, instrument, apparatus, implement, or system, whether used alone or in combination, intended for use in the examination of specimens taken from the human body.
SaMD Changes: Modifications to the SaMD that could affect its safety or performance.
SaMD Manufacturer: The person or organization responsible for designing and manufacturing the SaMD.
Intended Use/Intended Purpose: The use or purpose for which the SaMD is intended, as specified by the manufacturer.

Key Points

The document provides a common framework for regulators to incorporate converged controls into their regulatory approaches for SaMD.
The definitions and terms developed in this document will be used to develop future documents that provide a common framework for identifying types of SaMD and associated risks and controls.
* The objective is to promote consistent expectations for SaMD and to provide an optimal level of patient safety while fostering innovation and ensuring patients and providers have continued access to advances in healthcare technology.