FDA Device Guidance: General Wellness: Policy for Low Risk Devices

This article walks through the general wellness guidance, in which FDA provides many examples of devices they consider to be low risk general wellness products. The guidance, which spends a lot of time on general health and fitness mobile apps, makes clear FDA does not intend to regulate such products. Products classified as “medical devices” either need to be approved by FDA through pre-market approval or show that they are substantially equivalent to an existing device. Both processes take time and resources, so avoiding the designation is in a company’s best interest. Thus, FDA’s guidance on whether a product is a “general wellness product” instead of a medical device is a very useful document. FDA states that a general wellness product has: (1)  An intended use that relates to a maintaining or encouraging a general state of health or a healthy activity, or (2)  An intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition. The first category of general wellness intended uses involves claims about sustaining or offering general improvement to conditions and functions associated with a general state of health that do not make any reference to diseases or conditions. Such claims can relate to diet, fitness, or impr...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs