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  5. What are examples of Software as a Medical Device?
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What are examples of Software as a Medical Device?

What are examples of Software as a Medical Device?

Software as a Medical Device ranges from software that allows a smartphone to view images obtained from a magnetic resonance imaging (MRI) medical device for diagnostic purposes to Computer-Aided Detection (CAD) software that performs image post-processing to help detect breast cancer.

Other examples include:

  • Software as a Medical Device may be interfaced with other medical devices, including hardware medical devices, and other software as a medical device software, as well as general purpose software. Software that provides parameters that become the input for a different hardware medical device or other Software as a Medical Device. For example, treatment planning software that supplies information used in a linear accelerator is Software as a Medical Device.
  • Software with a medical purpose that operates on a general purpose computing platform, i.e., a computing platform that does not have a medical purpose, is considered Software as a Medical Device. For example, software that is intended for diagnosis of a condition using the tri-axial accelerometer that operates on the embedded processor on a consumer digital camera is considered Software as a Medical Device.
  • 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 Software as a Medical Device and not an accessory to the hardware medical device.
  • Software as a Medical Device is capable of running on general purpose (nonmedical purpose) computing platforms. Software as a medical device running on these general purpose computing platforms could be located in a hardware medical device.

What are examples of software that are not Software as a Medical Device?

If the software is part of a hardware medical device, it does not meet the definition of Software as a Medical Device. Examples 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 Software as a Medical Device.
  • Software required by a hardware medical device to perform the hardware's medical device intended use, even if 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.
  • Software that enables clinical communication and workflow including patient registration, scheduling visits, voice calling, and video calling.
  • Software that monitors performance or proper functioning of a device for the purpose of servicing the device, (e.g., software that monitors x-ray tube performance to anticipate the need for replacement), or software that integrates and analyzes laboratory quality control data to identify increased random errors or trends in calibration on IVDs.
  • Software that provides parameters that become the input for software as a medical device is not software as a medical device if it does not have a medical purpose. For example, a database including search and query functions by itself or when used by Software as a Medical Device.

If you have a question about whether your software is software as a medical device, please email digitalhealth@fda.hhs.gov.

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