OTC Medical Devices

Medical devices 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 medical device. Manufacturers rely on labeling, design, and consumer familiarity to ensure safe and effective use. Most medical devices are not subject to FDA’s premarket review requirements.

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Regulation of OTC Medical Devices
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OTC Medical Device Statistics

Browse OTC Medical Devices Content

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Voluntary Codes and Guidelines

Voluntary Codes and Guidelines
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Membership

CHPA is the home for responsible members of the consumer healthcare community. We represent leading manufacturers, and the companies that service them, in the area of OTC medicines, dietary supplements, and OTC medical devices.

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FAQs

FAQs About OTC Medical Devices
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Podcast

CHPA Chat
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Event

Meetings and Education Calendar

Save the date for upcoming CHPA meetings and events!

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Publications

State & Local Reporter

CHPA's member-only weekly report from our State & Local Government Affairs team, reporting on recent legislative activity around the country affecting our industry.

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Weekly Voice

Federal Register (FR) Notices, October 10, 2022
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Regulation of OTC Medical Devices
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State Government Reports

View members-only reports outlining progress on CHPA state legislative priorities.

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Research & Data

CHPA strives to continually reinforce, define, and quantify the value of consumer healthcare products for consumers and the healthcare system. These CHPA research initiatives and products highlight the meaningful ways that consumer healthcare products provide consumers access to trusted, affordable, empowering self-care options.

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