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.
Legislation exempting certain consumer medical devices from sales and use tax is under consideration in state legislatures across the country. So far this year, lawmakers in seventeen states have considered bills that would exempt either menstrual products, adult incontinence products, or both.
Boomers are a diverse demographic with different health needs, preferences, and shopping behaviors. The demand for holistic products that enable self-care make boomers ripe for engagement and highlight an opportunity for the self-care products industry.