The Food and Drug Administration (FDA) is issuing this
guidance document to provide clarity to industry and FDA staff on the Center
for Devices and Radiological Health’s (CDRH’s) compliance policy for low risk
products that promote a healthy lifestyle (general wellness products). This guidance does not apply to products (e.g.,
drugs, biologics, dietary supplements, foods, or cosmetics) regulated by other
FDA Centers or to combination products.
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