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.
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.
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.
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.
Statement on Biden Executive Order Regarding OTC Hearing Aids from Peter Borsuk, Chair of CHPA’s Consumer Medical Devices Council, and President & CEO of Lansinoh Laboratories.
Prior to the pandemic, the self-care sector was already expanding rapidly, with health spending increasing 31-fold per capita over the past four decades. IRI and CHPA recently released this report about how consumer self-care has specifically changed.
