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.
CHPA supports FDA's goals of reducing medical errors, simplifying device use information into data systems, identifying devices with adverse events, facilitating recall efficiency, and focusing communication.
CHPA's member-only weekly report from our State & Local Government Affairs team, reporting on recent legislative activity around the country affecting our industry.
Imposing extended producer responsibility (EPR) laws on medical device makers would be an excessive regulation given that most major companies in the industry have already implemented voluntary programs for free consumer battery recycling.
The Health in Hand Foundationleads influential, innovative educational initiatives that address specific areas where consumers need guidance and support.
