The U.S. Food and Drug Administration has issued two draft guidance documents outlining its current thinking about low-risk devices intended to promote general wellness as well as the regulatory agencys risk classification approach to medical device accessories.
Under the proposed guidance, general wellness products can include exercise equipment, audio recordings, mobile apps, video games, and other products that are typically available from retail establishments.The FDA would not enforce regulatory compliance for low-risk general wellness devices designed to maintain or encourage a general state of health and that may associate a healthy lifestyle with reducing the risk or impact of certain diseases or conditions. Through this policy, the agency said it hopes to foster the development of low-risk devices intended to promote a healthy lifestyle.
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