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.
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.
CHPA's member-only weekly report from our State & Local Government Affairs team, reporting on recent legislative activity around the country affecting our industry.
The following CHPA research initiatives and products highlight the meaningful ways that OTC medicines provide consumers access to trusted, affordable, empowering self-care options.
