What is Software as a Medical Device (SaMD)?
What is Software as a Medical Device?
Software as a Medical Device (SaMD) refers to software that is intended to be used for medical purposes, without being part of a hardware medical device. SaMD is designed to provide medical information, support clinical decision making, or manage patient data.
Examples of SaMD include:
mobile apps that monitor vital signs
software that assists in the interpretation of diagnostic test results
and programs that provide personalized treatment recommendations.
SaMD must comply with regulatory requirements for medical devices and undergo rigorous testing and validation to ensure its safety and effectiveness. In the United States, the FDA regulates SaMD.
What does it take for a product to become classified as SaMD?
The International Medical Device Regulators Forum (IMDRF) is a global consortium whose members collaborate to develop similar regulatory requirements across countries. The FDA is an active member of IMDRF.
The FDA defines SaMD as “Software that meets the definition of a device in 181 section 201(h) of the FD&C Act and is intended to be used for one or more medical purposes without being part of a hardware device.”
The FDA cares about risk, safety, and efficacy of the products it reviews. They have multiple review pathways depending upon risk classification, with Class I being the lowest risk and Class III being the highest risk. There are clearly outlined processes on the FDA website on how to move forward with a review. For example, The 510(k) classification is the lowest risk and for new devices that are "substantially equivalent" to a predicate device in terms of intended use, technological characteristics, and performance testing.
It can take between a week and a year to complete the FDA review process.
Have I used Software as a Medical Device?
If you own a recent Apple Watch or Fitbit, you’ve likely used an FDA reviewed SaMD due to the product’s irregular heart rhythm notification. The software within the hardware (what you actually put on your wrist) analyzes pulse rate data and sends an alert when it detects a suspected abnormality. (Here’s Fitbit’s FDA review paperwork for the curious.) Continuous glucose monitors with a mobile phone app for people with diabetes are another example of SaMD you may have used. Ever had an MRI? It’s possible those images were sent to software to make diagnosis recommendations. That’s also SaMD. It’s becoming more and more prominent in medical practice.
I’m hearing a lot about Artificial Intelligence and Machine Learning…does SaMD use AL and ML?
Yes and no. There is a lot of SaMD on the market. Guidea lists over 500 products in their article!
In case you don’t know the difference between AI and ML:
Artificial Intelligence (AI) is an umbrella term for computer software that mimics human cognition in order to perform complex tasks and learn from them.
Machine Learning (ML) is a subfield of AI that uses algorithms trained on large data sets to produce adaptable models that can perform a variety of complex tasks.
Software may have its own priorietary algorithm as part of its ‘brain’ that is not trained on artificial intelligence or machine learning models. But other companies might use AI or ML as part of its code.
Additional Resources
IMDRF report on Software as a Medical Device (Dec 2013)
FDA report: SaMD Clinical Evaluation: Guidance for Industry and Food and Drug Administration Staff
FDA: Your Clinical Decision Support Software: Is it a Medical Device?
FDA: Artificial Intelligence and Machine Learning in Software as a Medical Device
