Consumer Medical Devices

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.

Select an Issue

Browse Consumer Medical Devices Content

Orange CHPA logo on dark blue background

Weekly Voice

Federal Register (FR) Notices, December 3, 2021

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.

Dec 2, 2021

woman in hat running at sunset

Submission

Comments Regarding Draft Guidance on Electronic Submission Template for Medical Device 510(k) Submissions

CHPA welcomes FDA’s efforts to modernize and streamline the process for creating and submitting 510(k) premarket notifications and generally supports the approach described in the Draft Guidance. However, CHPA recommends that FDA clarify the following key points when finalizing the Draft Guidance.

Nov 23, 2021

Orange CHPA logo on dark blue background

Weekly Voice

Federal Register (FR) Notices, November 19, 2021

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.

Nov 18, 2021

FDA headquarters sign in Washington DC

Press Releases and Statements

CHPA Statement on President Biden’s Nomination for FDA Commissioner

The Consumer Healthcare Products Association (CHPA) issued the following statement today from Scott Melville, president and CEO, regarding the nomination of Robert Califf, M.D. as the next U.S. Food and Drug Administration (FDA) commissioner.

Nov 12, 2021

Orange CHPA logo on dark blue background

Weekly Voice

Federal Register (FR) Notices, November 12, 2021

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.

Nov 10, 2021

Orange CHPA logo on dark blue background

Weekly Voice

Federal Register (FR) Notices, November 5, 2021

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.

Nov 3, 2021

Orange CHPA logo on dark blue background

Weekly Voice

Federal Register (FR) Notices, October 29, 2021

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.

Oct 27, 2021

Orange CHPA logo on dark blue background

Weekly Voice

Federal Register (FR) Notices, October 22, 2021

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.

Oct 20, 2021

FDA headquarters sign in Washington DC

Press Releases and Statements

FDA Proposes the Creation of a Regulatory Category for OTC Hearing Aids

FDA issued a long-awaited proposed rule which has the potential to positively affect the lives of millions of consumers by increasing access to affordable over-the-counter (OTC) hearing aids and personal sound amplification products for those who experience hearing loss.

Oct 19, 2021

Orange CHPA logo on dark blue background

Weekly Voice

Federal Register (FR) Notices, October 8, 2021

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.

Oct 8, 2021

Filter Results