Software as a Medical Device? Here’s What the FDA is Saying

Throughout the years, as technology has continued to evolve, software has become an essential part of products used in all facets of healthcare.

Widely integrated into digital platforms that serve both non-medical and medical purposes, software on its own is a medical device but Software as a Medical Device (SaMD) is one of three types of software related to medical devices.

What does Software as a Medical Device Mean?

According to the FDA, the term “Software as a Medical Device”, or SaMD, has been defined by the International Medical Device Regulators Forum as “software that is intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”

Over the last four decades, the number of medical devices used across the globe has increased to around 1.5 million devices. The amount of software used in these devices has taken the biggest leap in the last 20 years with the emergence of “internet of things” (IoT) and other corresponding technology. As technology like smartphones, wireless connectivity, cloud computing, and artificial intelligence transform how work is done in and out of the medical industry, software is an increasingly prevalent component, especially for highly sophisticated devices.

What are Similar Terms to SaMD?

Software as a Medical Device can be used across a broad range of technology platforms, including medical device platforms, commercial "off-the-shelf" platforms, and virtual networks. As such, this kind of software was previously referred to as other terms including “Standalone Software,” “Medical Device Software,” and/or “Health Software” depending on industry, international regulators, and health care providers.

Though the use of these terms seems harmless there are actually quite some differences between them. While SaMD is considered a standalone software, medical software or health software is embedded into devices with a specific purpose like improving patient experience or optimizing treatment.

What are the Current Challenges with SaMD?

Considering the unique features of Software as a Medical Device that expands traditional medical devices or software, regulators recognize the need for principles for SaMD that will allow stakeholders to promote safe innovation and protect patient safety. In 2013 the International Medical Device Regulators Forum (IMDRF) formed the Software as a Medical Device Working Group (WG) to develop supporting innovation and timely access to safe and effective Software as a Medical Device globally.

Over the last years, WG has agreed upon these key definitions for SaMD:

  • Framework for risk categorization
  • Quality Management System
  • Clinical evaluation

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