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What would be the Level of Concern of Windows or iOS (off-the-shelf software) for a piece of software running on a PC or iPhone that has a Moderate Level of Concern? Does the off-the-shelf software level of concern have to match that of the software medical device?
In the off-the-shelf software guidance (http://www.fda.gov/downloads/MedicalDevices/.../ucm073779.pdf), there are a few examples starting on page 12. In each example though, in the section on OTS Software Level of Concern, it focused on the role of what the software did, even though it previously mentioned the OTS software was Windows. So that confused me about the Level of Concern for the operating system.