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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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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Strategic Priorities
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Batteries in OTC Medical Devices

Imposing extended producer responsibility (EPR) laws on medical device makers would be an excessive regulation given that most major companies in the industry have already implemented voluntary programs for free consumer battery recycling.

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