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

Athlete Outside with Fitness Tracker on a running track
Regulation of Consumer Medical Devices
Young brown haired child brushing teeth
Consumer Medical Device Statistics

Browse Consumer Medical Devices Content

Federal Register Notice graphic image with flag, capitol building, and gavel

Newsletters

Federal Register (FR) Notices, Friday, January 7, 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. 

Jan 6, 2022

Orange CHPA logo on dark blue background

Articles

CHPA Delivers Key Wins in 2021!

Jan 4, 2022

Federal Register Notice graphic image with flag, capitol building, and gavel

Newsletters

Federal Register (FR) Notices, Friday, December 17, 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 15, 2021

Federal Register Notice graphic image with flag, capitol building, and gavel

Weekly Voice

Federal Register (FR) Notices, December, 10, 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 9, 2021

FDA headquarters sign in Washington DC

Submission

Comments Regarding UDI Draft Guidance

While CHPA supports FDA’s issuance of a final policy regarding GUDID submission requirements for consumer health devices, CHPA believes that the Agency should: (1) clarify the definition of “consumer health device” used in the draft guidance; and (2) consider expanding the scope of consumer health devices covered by the guidance to not only include class I, but certain class II and unclassified OTC devices.

Dec 8, 2021

Federal Register Notice graphic image with flag, capitol building, and gavel

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

Federal Register Notice graphic image with flag, capitol building, and gavel

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

Federal Register Notice graphic image with flag, capitol building, and gavel

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

Filter Results