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SaMD - Software as a Medical Device - The Quick Guide

March 14, 2022
Michelle Wu, Qiang Kou (KK)
SaMD - Software as a Medical Device - The Quick Guide

What is SaMD?

The International Medical Device Regulators Forum (IMDRF) defines software as a medical device as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” This is the definition that the Food and Drug Administration (FDA) also uses.

SaMD is software that can be used with non-medical devices like smartphones, tablets, computers, and watches. Some examples of this might be:

●       BMI and body fat calculators

●       Image processors for cancer, x-rays, and more

●       The software that regulates a device, like an insulin pump or pacemaker

●       Sleep data apps that supply data to a sleep lab

These software applications are used by medical professionals to provide them with data for diagnosis or monitoring of a patient, a condition, or an installed device.

How does the FDA regulate SaMDs?

The FDA, as with everything else that’s intended to be used by the medical community, evaluates SaMDs on three basic criteria: clinical safety, effectiveness, and performance as intended by the manufacturer.

  1. Is the software safe for use? While a piece of software might not kill someone directly, if it is chronically incorrect, it might lead to underdosing or overdosing of a drug. This can lead to health issues or death.
  2. Is it effective? If the software purports to monitor heart rate, but it monitors respiration, it’s not effectively doing that job it was created for.
  3. Does it perform correctly? The device needs to be consistently reliable for data on the condition that it monitors.

FDA SaMD regulation is developing quickly. The latest clinical guidance form the FDA can be found in “Software as a Medical Device (SaMD): Clinical Evaluation - Guidance for Industry and Food and Drug Administration Staff ''. This publication details everything that the FDA expects from the industry regarding the devices it develops. The present version dates from December of 2017.

Along with the FDA regulation of these devices, there are also international industry standards.

ISO has issued guidance on the life cycle requirement for medical device software.

“The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes.” ISO 62304 is the industry standard that digs deeper into the creation, regulation, and security of SaMDs, providing developers with guidance that’s much more complete than the FDA guidelines.

What are the regulatory challenges?

The regulatory challenges are many, but most significant is that, since there is no “manufacturing” time and no physical location of manufacture, as there might be with hardware, software can be deployed in seconds by the creator. This might create a “Wild West” of software that’s ineffective at best and misleading or dangerous at worst.

To counter this, regulators worldwide created the IMDRF to help regulate the global production not only of hardware but also software for health applications. Since the global economy allows the movement of hardware and software easily, it’s important that the entire world agrees with regulations to protect everyone.

In 2013, the IMDRF “agreed upon the key definitions for Software as a Medical Device, framework for risk categorization for Software as a Medical Device, the Quality Management System for Software as a Medical Device, and the clinical evaluation of Software as a Medical Device.”

What is the industry perspective of SaMDs?

There are many detractors of Software as a Medical Device. Most times, the bias of those who are negative about SaMDs can be seen clearly in their business affiliations. Many are in the business of selling hardware that does the same functions as up-and-coming SaMD applications.

Some write about the lack of regulation, while others lament the security protocols that are put in place to protect patient privacy and the software from hackers.

Those who look at SaMDs from a more neutral eye see it as a way to make medical information and diagnosis easier to use. If a physician has a tablet in a poor clinic, they can use an inexpensive or free SaMD program to monitor and diagnose patients, whereas the hardware might be far out of reach financially.

Even something as simple as a BMI calculator can be life-saving in the hands of physicians helping patients avoid diabetes and heart disease.

The industry is enthusiastic. Of course, the significant cost of software is in the development. Once developed, distribution of the software is free or nearly free. “Manufacture”, the duplication of the software, is also free. The applications can be used on the devices that professionals and patients already own.

What is the future of SaMDs?

According to, the SaMD industry is expected “to grow at a CAGR of 69.30% during the forecast period of 2019-2026.” Nearly 70% growth in any industry is breathtaking.

The report, published in 2021, doesn't consider the changes in lifestyles and medicine brought on by the COVID-19 pandemic. In the past two years, millions of people have had the time to take more of their health into their own hands, and SaMDs are ideal for that purpose.

Software as Medical Devices are likely to become the most prominent part of the medical industry in a decade or less. Since the software can sell for much less than hardware, using software to promote good health will help make great health information available to physicians and patients all over the world for far less than has ever previously been possible.

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