Software as a Medical Device (SaMD) is defined as software intended to be used for a medical purpose without being part of medical device hardware.
- Includes in-vitro diagnostics (IVD)
- Applications running on general purpose computers
- “without being part of” means software not necessary for a hardware medical device to achieve its intended medical purpose
- May be used in combination (e.g., as a module) with other products including medical devices
- SaMD may be interfaced with other medical devices, including hardware medical devices and other SaMD software, as well as general purpose software
- Mobile apps that meet the definition above are considered SaMD
- Software is NOT considered a medical device if its intended purpose is to drive a hardware medical device.
Examples of software that ARE SaMD:
- Software with a medical purpose that operates on a general-purpose computing platform, e.g. software that is intended for diagnosis of a condition using an embedded processor on a consumer digital camera is considered a SaMD.
- Software that is connected to a hardware medical device but is not needed by that hardware medical device to achieve its intended medical purpose is SaMD and not an accessory to the hardware medical device, e.g. software that allows a commercially available smartphone to view images for diagnostic purposes obtained from a magnetic resonance imaging (MRI) medical device is SaMD and not an accessory to MRI medical device.
Examples of software that are NOT SaMD:
- Examples of software that are considered “part of” include software used to “drive or control” the motors and the pumping of medication in an infusion pump; or software used in closed loop control in an implantable pacemaker or other types of hardware medical devices. These types of software, sometimes referred to as “embedded software”, “firmware”, or “micro-code” are, not SaMD”.
- Software required by a hardware medical device to perform the hardware’s medical device intended use is not SaMD even if/when sold separately from the hardware medical device.
- Software that relies on data from a medical device, but does not have a medical purpose, e.g., software that encrypts data for transmission from a medical device is not SaMD.
- Software that enables clinical communication and workflow including patient registration, scheduling visits, voice calling, video calling is not SaMD.
- Software that monitors performance or proper functioning of a device for the purpose of servicing the device.