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.
For its annual year-in-review series, Chain Drug Review featured CHPA's President & CEO, Scott Melville, who offered industry insights from last year and thoughts on the outlook for 2021.
We want to thank you, our members, for your patience and understanding during difficult times. Here you may find up to date information about our event offerings for 2021.
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.
Women spend an estimated $4,752 on tampons and pads throughout their lifetime, which doesn't account for other menstrual health-related products they'll use.
Enclosed herein are comments on "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device: Public Meeting: Request for Comments".
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.
