CHPA Statement Regarding FDA Authorization of OTC Self-Test Kits for COVID-19

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Press Releases and Statements | Apr 2, 2021

“The Consumer Healthcare Products Association (CHPA) applauds FDA’s recent emergency use authorization for a number of over-the-counter (OTC) nonprescription self-testing products for COVID-19. Consumer medical devices, including diagnostic products like these, are critical health tools that enable consumers to monitor and self-assess their COVID-19 status quickly, safely, accurately, and frequently without spending time or money on visits to a doctor’s office. OTC consumer medical devices help save $8 billion in other costs to the U.S. healthcare system each year.

            “The critical importance of consumer medical devices to public health has been highlighted during the COVID-19 pandemic with Americans relying on devices such as face masks, thermometers, pulse oximeters, analgesic patches, surgical gloves, and many other products to help monitor their health, to get well, and to stay well. Now, access to OTC self-test kits empowers even more self-care, which is especially important as states are loosening pandemic-related social restrictions, Americans begin returning to schools and offices, and the summer travel season approaches.”

Founded in 1881, the Consumer Healthcare Products Association (CHPA) is the national trade association representing the leading manufacturers and marketers of over-the-counter (OTC) medicines, dietary supplements, and consumer medical devices. Every dollar spent by consumers on OTC medicines saves the U.S. healthcare system more than $7, contributing a total of $146 billion in savings each year. CHPA is committed to empowering consumer self-care by preserving and expanding choice and availability of consumer healthcare products.