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.
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.
CHPA is rebranding its identity for the first time in 20 years. The rebranding effort has resulted in a new logo, tagline, and brand narrative following the addition of consumer medical devices to its scope of representation.
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.
