Whether the medical software device provides individualized patient care recommendations, e.g., whether the software suggests or recommends specific treatment for a specific patient. Example: How specific is the software output with regard to particular patients? Is the software providing general advice or information, like a library, article, or textbook, or is the software designed to provide a specific recommendation for a specific patient whose individual data have been entered as input?
Whether the mechanism by which the medical software device arrives at a decision is hidden or transparent, i.e., does the product use undisclosed parameters or internal decision trees or other mechanisms that are not available for review by the health care provider. Example: How transparent is the software manipulation to the intended user community? Included in transparency is the extent to which limitations on the process are made known to the user, such as data contraction, deletion, editing, or simplification. Also, how are comparisons made to normative databases and how are normative databases created?
Does the product provide new capabilities or intended uses for the user?
Until FDA decides to further clarify the middle category of regulated but exempt from premarket notification, a practical consideration of those factors should help the company decide whether in FDA’s eyes the software is risky enough to require premarket clearance. As I said, you won’t find that in any existing FDA guidance or regulation. That’s just based on practical observation.
Software Requiring FDA Pre-market Clearance
In the second article in this series, I outlined generally the approach for securing FDA clearance. In the case of software, the first step is identifying the most appropriate classification from among the roughly 1700 classification regulations. The word software is contained in 431 different regulations, so it’s not an easy task.
Remember that software that accessorizes a medical device is classified with that medical device. So if a cell phone app allows for the downloading of blood glucose data, the app is classified with the blood glucose meter and regulated to the same degree. As another example, if the app is designed to help with medication management, there is a specific classification for such software in 21 C.F.R. § Sec. 880.6315. This can obviously get very complex in an interconnected system, perhaps on a wireless network, but that’s too much for this article.
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