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.
Here are the Federal Register notice summary excerpts that might be of interest to you or others within your organization. Please see notices for complete details.
The Consumer Healthcare Products Association (CHPA) released a statement today upon the U.S. Food and Drug Administration (FDA) final rule establishing a regulatory category for over-the-counter (OTC) hearing aids.
Here are the Federal Register notice summary excerpts that might be of interest to you or others within your organization. Please see notices for complete details.
