What is software as a medical device?

Software as a medical device, or SaMD is software that is intended for one or more medical purposes. This software performs those purposes without being part of a hardware medical device. 

SaMD devices also need to meet the definition of a device in 181 section 201(h) of the FD&C Act as defined by the FDA.  

Despite the above definitions, there is still confusion across the medical device industry as to what exactly SaMD is.

Unsure if your product is a software as a medical device?

You’re not alone. Software as a medical device can be tricky to navigate.

As the FDA is a member of the International Medical Device Regulators Forum (IMDRF), there’s no escaping the obligations and potential risks involved if you don’t meet the definitions outlined above. 

This white paper explores everything you need to know in a simple format. It explores everything from:

• Characterizing your SaMD accurately by defining its intended use and indications for use
• Providing a simple explanation of the difference between SaMD and SiMD
• Exploring the global and U.S specific regulations around software as a medical device
• Providing helpful SaMD examples
• Exploring maintenance plans, risk and configuration management
• Explaining cybersecurity and post-market requirements and so much more.

So, let’s take a closer look at what software as a medical device is, what it isn’t, and how you can determine if your product fits the definition.