FDA guidance offers clarity on wellness products

Laura Pedulli | | Health Exec | Policy & Regulations

The FDA has released a draft guidance offering some clarity on how it defines a low-risk product: A general wellness product becomes a medical device when it refers to its use for a specific disease or condition, according to Medcity News. 

The draft guidance takes a pragmatic approach, but several wearables companies are working with medical research centers to assess their technology for specific conditions--complicating the picture. FDA is seeking feedback on the guidance for the next 90 days, according to the story.

Read more below:

FDA offers proposed guidance on when a wellness product becomes a medical device

Laura Pedulli

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