SaMD – Software as a Medical Device is a Game Changer


Author: Timothy Reynal


Software as a medical device, or SaMD, is a fast-emerging technology that is transforming how health care allows us to be less dependent on direct care providers; lets doctors remotely monitor our diseases, injuries and healing without in-patient care; warns us when a medical condition requires intervention; and performs accurate diagnoses.

Every aspect of our lives today is affected by software: our comfort, our learning, our day-to-day convenience, our travel, our security, our jobs, our data, our communications, our relationships…and our health.  As consumers, we trust that the functionality of software will perform reliably and safely.  The Food and Drug Administration partners with its international counterparts to ensure any software that works as a medical device or in concert with a medical device has proven safe and passed FDA muster based on its intended use.  The process to get FDA approval of an SaMD is deliberately thorough and arduous.

Specifically, SaMD is “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”

The FDA lists examples of SaMD to include software that allows a patient to view MRI images on their smartphone or Computer-Aided Detection (CAD) software that performs detection of breast cancer.

Smartphones as an SaMD platform

Almost every adult today owns a smartphone which may host medical software.  We take them almost everywhere we go and have them near us more than any other item we possess, making it an ideal platform for SaMD.  Without additional peripheral devices, they can monitor our vital signs, track our exercise, log the food we eat, transmit blood glucose data and warn us of any health abnormalities.  This data can be shared electronically with our doctors either in real time or through periodic data uploads.

Medical engineers are quickly developing new SaMD applications that will continue to revolutionize how smartphones will increasingly become our surrogate medical practitioner.

Is all medical software considered SaMD?

No.  Software that is used to directly control a medical device or embedded firmware on a medical device is not SaMD.

Other exclusions are best defined by the FDA and include:

  • “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.”

FDA Regulatory ComplianceSaMD

Designing, building, testing and delivering SaMD requires adherence to the FDA’s risk-based certification – minimizing the probability of occurrence of harm as a result of the software’s output.  This is a distinguishing difference from Software in A Medical Device (SiMD) where the risk is based on the device failure which can harm the patient.

The FDA requires a Quality Management System (QMS) compatible with their Mobile Medical Device regulations which encompasses good “cyber hygiene” in order to release SaMD.

Advantu is ready to augment your software team with our expert guidance and consultants to ensure that you minimize your FDA rejections and maximize your FDA approvals by developing a solid QMS…and getting your software to market with no hiccups.


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