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.
The Consumer Healthcare Products Association (CHPA) released a statement today upon the U.S. Food and Drug Administration (FDA) final rule establishing a regulatory category for over-the-counter (OTC) hearing aids.