Health Care & Hospital Law
Jan. 30, 2015
FDA's general wellness guidance is welcome news
The FDA just issued a draft guidance which sounds like good news for manufacturers and distributors of "low risk products that promote a healthy lifestyle." What does that mean for industry? By Michael H. Cohen
The FDA just issued a draft guidance titled "General Wellness: Policy for Low Risk Devices." This sounds like good news for manufacturers and distributors of what the FDA now calls, "low risk products that promote a healthy lifestyle (general wellness products)."
But what exactly are those products and is the FDA really lowering the barrier for industry?
Start with the "intended use" doctrine...
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