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

Browse Consumer Medical Devices Content

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Podcast

CHPA Chat - A Global Perspective on the Self-Care Readiness Index

May 31, 2022

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Newsletters

Federal Register (FR) Notices, Friday, May 27, 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.

May 25, 2022

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Submission

Comments on the Proposed Rule: Medical Devices; Quality System Regulation Amendments

CHPA supports efforts to harmonize the current Quality System Regulation with international quality management system requirements. However, CHPA recommends that FDA address several points of concern or clarification when finalizing the Proposed Rule.

May 24, 2022

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Podcast

CHPA Chat - Digital Health and the Future of Consumer Medical Devices

On this episode of CHPA Chat, we're talking about the explosion in digital health. Not just the watch you may be wearing, but technology that could enable healthcare, and very importantly self-care. Today, we're talking about digital health, what it means for the industry, and what the future holds for this rapidly growing sector.

May 16, 2022

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Podcast

CHPA Chat - Sexual Health, an Integral Part of Self-Care

In today's episode, we're discussing a topic that doesn't often get the attention it needs — sexual health. Join Anita Brikman and Bruce Weiss as they explore the state of sexual health in the US today and the role that OTC sexual health products play.

May 2, 2022

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Weekly Voice

Federal Register (FR) Notices, Friday, April, 15, 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.

Apr 14, 2022

Video

Thank You for Joining Us at SLS 2022

Apr 7, 2022

Weekly Voice Teaser

Weekly Voice

Federal Register (FR) Notices, April 1, 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.

Mar 30, 2022

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Press Releases and Statements

CHPA Statement on FDA FY2023 Budget Request

The Consumer Healthcare Products Association issued a statement from President and CEO Scott Melville regarding the Food and Drug Administration’s (FDA) fiscal year 2023 budget request.

Mar 28, 2022

Weekly Voice Teaser

Weekly Voice

Federal Register (FR) Notices, March 25, 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.

Mar 23, 2022

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