Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in eHealth Law & Policy Journal, in “FDA Guidance Confirms Agency Won’t Actively Regulate Low Risk General Wellness Products.”
Following is an excerpt:
Thompson believes that the Guidance “clears the air and allows the wearables industry to grow and flourish. It sets relatively clear parameters around what can be said, thus allowing makers of wearables to promote their products with confidence, and without fear of FDA regulation so long as they respect the guideposts. Frankly the Guidance means that wearable manufacturers can target sufferers of chronic disease so long as their products actually do help people live healthy lives with a chronic disease, so long as they don't suggest that their wearables actually treat the disease.”