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FDA Regulatory Requirements for Medical Device Software (SaMD and SiMD)

Let’s start with US FDA requirements.


How Does US FDA Regulate Medical Device Software?

FDA is years ahead of other regulators, including Europe, when it comes to the specificity of regulatory guidance pertaining to medical device software. FDA has been publishing software guidance documents for more than 20 years and has been especially prolific in the last 3 to 5 years. To their credit, FDA recognizes the importance (and prevalence) of software in all sorts of devices and is making a concerted effort to ensure that its regulatory framework does not stifle innovation. In recent years, new or updated guidance has been published covering all sorts of issues, including:

  • Plus, several more! See the entire list know more.

FDA guidance is not the only thing you should follow. A variety of international standards go even further into the weeds on topics such as medical device cybersecurity, interoperability, life-cycle management, and more.


FDA Requirements for Off-the-Shelf (OTS) Medical Device Software

Off-The-Shelf Software Use in Medical Devices: Guidance for Industry and Food and Drug Administration Staff, SEPTEMBER 2019


How Does Europe Regulate Medical Device Software?

Other software guidance documents published by the European Commission include:


Want to Learn More?

This article has only scratched the surface of the regulations that pertain to medical device software in the US and Europe. Take the next step with our in-depth training class on medical device software regulations and standards. It will give you the knowledge and confidence you need to ensure full compliance with the EU MDR, IVDR, and FDA regulations related to software.

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