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.
This past week, the House of Representatives adjourned for its annual August recess, although the House Democratic Leadership indicated that members would be called back sometime in August, should the Senate pass the Inflation Reduction Act of 2022.
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 requests an extension to the “Immediately in Effect Guidance for Industry and Food and Drug Administration Staff: FDA Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking,”
