Consumer medical devices (CMD) are sold over-the-counter (OTC) at non-specialty retail locations including drug stores, grocery stores, convenience stores, and online. They have established safety profiles and are for use by consumers in non-clinical environments. Generally, no training is necessary to use a CMD. Manufacturers of CMDs rely on labeling, design, and consumer familiarity to ensure safe and effective use. Most CMDs are not subject to FDA’s premarket review requirements.
