The definition of medical device under the FDA law and rules is quite broad. For makings of health care software, equipment and devices, it is not a trivial exercise to try to understand if you might be subject to FDA jurisdiction. As smart phone, tablet and other wireless device use has exploded, a large number of consumer and professional health care devices and applications have been created and marketed. The FDA recently issued a draft guidance designed to help vendors understand what they may need to do to comply with the medical device regulations. (Wellness Guidance) The first guidance is specifically directed at “wellness” devices and is a guidance for “low risk” ones. Using the usual FDA weasel words, it says that the FDA won’t examine “low risk general wellness products” to determine if they are devices as defined by the law. So how do you know if your product is a general wellness product? They have to be only for that use and they have to present a “very low risk” to users’ safety. According to the FDA, they could be exercise equipment, video games, audio recordings, software programs, usually available at retail outlets. So far, not much help. Here is a little more. A general wellness product is one that has “an intended use that relates to a maintaining or encouraging a general state of health or a healthy activity” or the associates the role of a healthy lifestyle with reducing the risk of chronic disease. It can’t make any claims in regard to specific diseases, but can refer to weight management, physical fitness, relaxation or stress management, self-esteem, sleep management or sexual function. Any claims that a product will help diagnose or treat a specific disease or condition makes it not a “general wellness product”. So you can’t say it will treat obesity or anxiety. It is okay, however, to claim your product has a use that will promote, track or encourage choices which may help reduce the risk of, or may help living well, with specific “chronic ” diseases. All clear now? And low risk means the product can’t be invasive, raise questions about biocompatibility, raise “novel questions about usability”, or involve an intervention or technology that may pose a risk to the user if controls aren’t applied. Clearer yet, eh! Anyhow, it is nice that they are trying.
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About this Blog
The Healthy Skeptic is a website about the health care system, and is written by Kevin Roche, who has many years of experience working in the health industry. Mr. Roche is available to assist health care companies through consulting arrangements through Roche Consulting, LLC and may be reached at [email protected].
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