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  • djr32 started the topic General Wellness Product in the forum Introduction to Project Management 8 years, 8 months ago

    According to the FDA, general wellness products are “(1) intended for maintaining or encouraging a general state of health or a healthy activity or (2) an intended use that related the role of a healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions.” The Center of Device and Radiology Health defines these products have two factors: (1) intended for ONLY general wellness use and (2) present a low risk to the safety of users and other people. (Look at the reference if further information is needed for general wellness products)
    The FDA categorizes general wellness products into 2 categories:

    (1) In the first category, the products intend to offer a general improvement to functions associated with general health that does not make any reference to diseases or conditions.

    (2) In the second category, the product intended uses relate to sustaining or offering a general improvement to function while making reference to diseases or conditions.

    Provide an example of a general wellness product, such as a Fitbit in the previous question I posted. What category does this general wellness product fall under? Why?

    Reference:
    http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674.pdf