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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Submission

Comments Regarding Provisions Pertaining to Preventing Access to U.S. Sensitive Personal Data and Government-Related Data

CHPA supports well-tailored efforts to protect the sensitive personal data of U.S. persons, including efforts intended to protect and strengthen the national security of the United States.

Nov 28, 2024

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Polibrief

Per-and Polyfluoroalkyl Substances (PFAS)

Fearing links to human health problems and harm to the environment, state lawmakers are increasingly seeking to restrict the use and/or presence of PFAS in consumer products and packaging, whether intentionally added or not.

Nov 20, 2024

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Polibrief

OTC Contraceptives

Today, common over the counter (OTC) contraceptives are affordable, readily accessible, and they play critical roles in reducing unintended pregnancies. Some of today’s most common forms of OTC birth control include male and female condoms, spermicides, birth control sponges, and emergency contraception.

Nov 20, 2024

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Polibrief

Consumer Medical Devices

CHPA monitors legislation in all 50 states and Washington, D.C., and takes positions per the direction of the State & Local Government Affairs Committee. As the role of CMDs in self-care continues to grow, so too will our engagement on issues at all levels of American government.

Nov 20, 2024

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Polibrief

OTC Sales Tax Exemptions

OTC medical devices like bandages, menstrual products, face masks, and at-home test kits, used for the purposes of prevention, testing, and treatment are well-accepted, cost saving elements of the healthcare system. Unfortunately, most states that have a retail sales tax, include a tax on the sale of some or all OTC healthcare products. More than 40 states, on the other hand, exempt sales tax of prescription drugs.

Nov 19, 2024

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Submission

Comments Regarding Predetermined Change Control Plans for Medical Devices;

CHPA supports FDA’s continued efforts to support medical device innovation by facilitating to the use of PCCPs for efficient Agency review of medical device modifications. When finalizing the Draft Guidance, CHPA strongly encourages FDA to provide further clarity regarding the content and process for PCCPs on several points.

Nov 19, 2024

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Press Releases and Statements

Statement of Congratulations to President-Elect and Vice President-Elect from CHPA CEO Scott Melville

Nov 6, 2024

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Submission

Comments Regarding FDA Diversity Action Plans to Improve Enrollment of Participants From Underrepresented Populations in Clinical Studies

CHPA supports the Agency’s directive to increase enrollment of participants from historically underrepresented populations in clinical trials to improve the strength and generalizability of the evidence to demonstrate safety and/or effectiveness of FDA-regulated medical products, but requests clarification on several points.

Oct 29, 2024

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Press Releases and Statements

Health In Hand Foundation Announces 2024 U.S. Self-Care Marketing Awards Finalists

(WASHINGTON, DC) – The Health In Hand Foundation today released the following statement announcing the 2024 U.S. Self-Care Marketing Awards finalists. Winners for each category will be announced at the 9th annual Health In Hand Foundation Gala on November 13 at The Bellevue Hotel in Philadelphia. Specific awards will recognize the strategic innovation and marketing expertise of CHPA member companies across over-the-counter (OTC) medicine, consumer medical device, and dietary supplement categories.

Sep 9, 2024

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Press Releases and Statements

CHPA Response to Study of Tampon Products

The Consumer Healthcare Products Association (CHPA) released the following statement in response to a recent study published in Environment International regarding the presence of metals in certain tampon products. The study did not assess the risk of metal exposure to tampon users.

Sep 6, 2024

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