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.

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Regulation of Consumer Medical Devices
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Consumer Medical Device Statistics

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Podcast

CHPA Chat - The Future of Digital Health at CES: Innovations and Insights

Step into the world of CES and explore the cutting-edge innovations in digital health. Join industry experts as they discuss the trends, highlights, and transformative potential of digital health showcased at CES.

Jul 17, 2023

Video

About CHPA 2023

Apr 17, 2023

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Press Releases and Statements

CHPA Educational Foundation Launches HealthInHand.org, Empowering People to Take Greater Control Over Self-Care Decisions

The Consumer Healthcare Products Association’s (CHPA) Educational Foundation today announced the launch of HealthInHand.org

Mar 1, 2023

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Podcast

CHPA Chat - Sound Insights: OTC Hearing Aids are Amplifying Consumer Self-Care

If you're one of the 30 million Americans experiencing hearing loss, here's some exciting news. OTC hearing aids are now available nationwide. It's a totally new way for consumers to care for their own hearing health, and an interesting look at how public health and digital technology can intersect.

Feb 27, 2023

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Submission

Comments Regarding Content of Human Factors Information in Medical Device Marketing Submissions

CHPA strongly encourages FDA to provide further clarity regarding the appropriate human factors information in premarket submissions that involve a change from prescription use to over-the-counter use and associated changes from a predicate device as compared to modifications to a sponsor’s own device.

Feb 21, 2023

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Submission

Comments on Proposed Rule Regarding Approach to PFAS Reporting Requirements and Supplier Notification for Chemicals of Special Concern

Feb 3, 2023

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Research Reports

CHPA Cybersecurity & Data Privacy Regulatory Landscape Scan

The purpose of this cybersecurity and data privacy regulatory scan is to understand the current and forthcoming regulatory landscape related to cybersecurity and consumer data privacy.

Jan 20, 2023

Retail Shopper

Articles

2023 Outlook for Consumer Healthcare

Don't miss CHPA President & CEO, Scott Melville's insights on the consumer healthcare industry for the year ahead. Check out this article from Chain Drug Review.

Jan 9, 2023

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Weekly Voice

Federal Register Notices for Week of December 19, 2022

Dec 20, 2022

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Weekly Voice

Federal Register (FR) Notices, December 5, 2022

Summary Excerpts from Select Federal Register Notices for CHPA Weekly Voice for the Week of November 21, 2022

Dec 8, 2022

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