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.
Policymakers should encourage – and empower – individuals to take responsibility for their oral health by supporting daily oral health self-care policies that make beneficial oral care products more accessible.
CHPA is the home for responsible members of the consumer healthcare community. We represent leading manufacturers, and the companies that service them, in the area of OTC medicines, dietary supplements, and consumer medical devices.
