General Wellness: Policy for Low Risk Devices

OMEDtechDraft Guidance

The FDA has issued a draft guidance document to provide information for low risk products that promote a healthy lifestyle. CDRH defines general wellness products as products that “are intended for only general wellness use, and present a very low risk to users’ safety.”  A general wellness product must either help to maintain a general state of health, or help to reduce the risk or … Read More