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.
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.
This week, the U.S. House of Representatives is poised to pass the America COMPETES Act. While CHPA supports consumer protections included in the COMPETES Act – the INFORM Consumers Act and the SHOP SAFE Act – there are some areas of concern.
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.
CHPA applauds the Agency’s efforts to create a regulatory category for OTC hearing aids to improve patient access for hearing aids, and to implement the hearing aid provisions of the FDA Reauthorization Act of 2017 (“FDARA”).
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.
