Medical devices 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 medical device. Manufacturers rely on labeling, design, and consumer familiarity to ensure safe and effective use. Most medical devices are not subject to FDA’s premarket review requirements.
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 2025 U.S. Self-Care Marketing Awards recognizes the strategic innovation and marketing expertise of our member companies in over-the-counter (OTC) medicine, dietary supplement, and OTC medical device industries.
