On January 20th, Food and Drug Administration (FDA) as published a draft guidance document, that’s available for public discussion within the next 90 days. This guidance was build up to help companies that are working in wellness devices and mobile apps to understand the position of their product and check if it crosses over into regulated medical device field.
As defined:“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 andaccepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.”
You can find the document here.
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