The Nemedio Blog:  Demystifying Compliance

your guide to product development and compliance for medical technology

General categories of software

September 27, 2022

Wondering about the different categories of software and how they relate to medical devices? Nemedio’s got you covered. This article will go over the major categories of software and their relation to medical devices. 

Software *in* a medical device

This category refers to software that is an essential component of a medical device. While this software is part of the device, there is a hardware component that is essential. The overall device is a medical device when the intended use of the device is to treat, mitigate, cure, or diagnose a disease or condition. Software in a medical device is regulated according to the device that the software is a part of - it’s not viewed as separate by the FDA. Your regulatory filings for your device will have to include information on your software, including its validation. Software in a medical device includes the software that controls things like surgical robots, pacemakers, brain-computer interfaces, and any other types of hardware.

Software *as* a medical device

This category of software is software that is intended to treat, mitigate, cure, or diagnose a disease or condition. There are many different types of software that fall under this category. This category includes software that delivers a disease diagnosis based on analyzing an image (like an MRI scan), or by analyzing a pattern of data (like an ECG signal). This category of software is regulated by the FDA, just like hardware medical devices. Apps that detect abnormal ECG features are an example of software as a medical device.

Software for health and wellness

Software for health and wellness has a limited set of marketing claims. In general, this type of software can only make claims like “may help with weight management”, or “promotes relaxation”. Wellness software can’t make claims about specific diseases or conditions, except when it’s used to promote healthy choices that may help reduce the risk of diseases. For example, software that promotes physical activity can claim it “may help reduce the risk of hypertension”. Also, wellness software can make claims about helping to live well with certain diseases. Another example would be a software product that tracks calorie intake, which can claim it “may help living well with type 2 diabetes.” 

Clinical decision support (CDS) software

The software in this category can analyze medical data, but there are strict limits to the type of data that can be analyzed and what the outputs of the analysis can be. There are 4 criteria that software needs to meet in order to be considered CDS software by the FDA. First, CDS software cannot acquire or process images or signals - if your software performs those functions, it’s a medical device. The next criterion is that CDS software is intended for displaying or analyzing medical information about a patient or other medical information, including peer-reviewed clinical studies or clinical practice guidelines. The third criterion is that CDS software is intended for supporting or providing a recommendation to a healthcare professional about the prevention, diagnosis, or treatment of a disease or condition. Note that the CDS is not making the diagnosis or recommendation itself - it provides information to the healthcare professional, who drives the clinical care. Finally, CDS software must enable the healthcare professional to review the basis for its recommendations - it can’t be a “black box.” When CDS software meets all these criteria, the FDA does not consider it a device, and it is not subject to medical device regulations. CDS software includes features like providing contextually-relevant information about a disease to a healthcare practitioner to provide a list of available FDA-approved treatment options based on the patient’s medical information.

Non-product software

Software in this category is not a medical device or part of a medical device. This includes software like quality management systems or software used for testing purposes only. While these software products might be essential to the manufacturing of your medical device, they are not themselves part of the product and are not regulated by the FDA as medical devices. Instead, non-product software is validated by software users for their specific use cases.

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We know it’s confusing trying to figure out what’s up with medical device software - you can take our quiz here to get a feel for what direction you might be headed in and then set up a free consultation to discuss the results.

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