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.
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.
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.
