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Updated OTS Software Use FDA Guidance: Don’t Drown in SOUP!

The FDA recently published updated guidance on “Off-The-Shelf Software Use in Medical Devices,” which is relevant to medical device manufacturers using readily available software components in their devices. Those familiar with IEC 62304 may recognize the similarities between “Off-The-Shelf Software” and “Software of Unknown Provenance” (SOUP).

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The FDA understands that leveraging OTS software allows manufacturers to focus resources on developing the software that performs the device-specific functions that make a device a “medical device”. 

However, manufacturers often do not have insight into the OTS software developer’s design and development process, lending to the software’s “unknown provenance”. Therefore, FDA recommends that manufacturers take a risk-based approach that considers the software’s intended use, complexity, and potential consequences of failure. The guidance does not change the procedures outlined in IEC 62304, including SOUP analysis. Rather it provides guidance on the documentation the FDA will look for in premarket submission to determine the suitability of OTS software in medical devices.

Manufacturers are advised to maintain a comprehensive documentation trail that outlines their assessment of OTS Software, which is in line with IEC 62304, regardless of whether the documentation will be provided in a premarket submission. 

This documentation should justify the manufacturer’s decisions regarding:  

        1. Software selection 
        2. Software integration into the medical device
        3. Software risk assessment
        4. Software verification and validation performed for the OTS software. 

IEC 62304
establishes three safety-based classifications that guide the activities that manufacturers should perform in evaluating SOUP. The activities outlined in IEC 62304 for each software class are still necessary and valuable, however the FDA diverges from this approach by outlining two tiers of requested documentation: a “Basic” and “Enhanced” Level of Documentation. The applicable Level of Documentation is “based on risks of its device software function(s) in the context of the device’s intended use.”

The Realtime Group has assisted multiple clients with determining software safety class, performing SOUP analysis, and creating documentation packages for regulatory submissions.  Contact a Realtime expert or give us a call today at 972-985-9100 and let us help you get your product to market.

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FDA Guidance on OTS Software Use:

IEC 62304: