Once you properly figure out which of the three roles the software plays, you can figure out its regulatory status. Typically that’s one of the following three choices:
Software that does NOT meet the legal definition of a device and is not regulated by FDA.
Software that does meet the legal definition of a device but is currently not actively regulated, and FDA is unlikely to require pre-market review.
Software that does meet the definition of a device and FDA is actively regulating and would require a pre-market review.
Except for a few specific exempt device types identified in the classification regulations, that middle category isn’t today a regulatory classification you’ll find defined in any FDA records. Fortunately or unfortunately, depending on your perspective, FDA has been very reluctant over the last dozen years to define with any real precision its policy on which types of software must undergo premarket review and clearance, or even approval. The agency has held open public meetings and floated concept papers, and more recently has proposed a limited device classification for medical device data systems, but by and large has not with any certainty clarified its policy on when software trips the premarket requirement.
So the following is just my personal observations about how FDA regulates software in practice, as I can glean from watching FDA enforcement actions, podium policy, and the informal statements FDA has made in concept papers.
Unregulated Software
In its explanation surrounding the agency’s proposed classification of Medical Device Data Systems published in 2008, FDA explains:
It is FDA’s long-standing practice to not regulate those manual office functions that are simply automated for the ease of the user (e.g., office automation)… For example, the report-writing functions of a computer system that allow for the manual (typewriter like) input of data by practitioners would not be… [regulated] because these systems are not directly connected to a medical device. In addition, software that merely performs library functions, such as storing, indexing, and retrieving information not specific to an individual patient, is not considered to be a medical device. Examples include medical texts or the Physician’s Desk Reference on CD-ROM that are indexed and cross-referenced for ease of use.
FDA goes on to say it won’t regulate “software that allows a doctor to enter or store a patient’s health history in a computer file.” On its face, that description of unregulated software is somewhat narrowly written. That is not surprising since FDA always takes an expansive view of its jurisdiction, and is not likely to concede much ground in that regard.
Beyond that passage, I would add that there are two key features for most unregulated software.
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