New FDA Webpage Brings OTC Medical Device Regulatory Information Into Focus

New Webpage Consolidates Existing Information in One Place
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Press Releases and Statements | Sep 14, 2021

For the first time, the U.S. Food and Drug Administration (FDA) has assembled a comprehensive webpage – Over-the-Counter Medical Devices: Considerations for Device Manufacturers – designed to assist manufacturers who are seeking approval or clearance of medical devices sold directly to consumers. This new online resource was a direct result of a request from the Consumer Medical Devices (CMD) Committee of the Consumer Healthcare Products Association (CHPA) which asked for a centralized source of information related to OTC device development from several different guidance documents. CMDs or “OTC devices” are those that may be offered for sale directly to the consumer and do not require a prescription, such as bandages, menstrual products, condoms, and oral care devices.

“This is a great example of FDA’s responsiveness and cooperation in solving a problem,” says Dr. Marcia Howard, CHPA’s vice president of scientific and regulatory affairs and the staff leader for CHPA’s CMD program. “Over the years, information on OTC devices had been scattered within multiple guidances and rules, generally focused on all types and classes of devices, with no single-source addressing OTC devices specifically.”

In early 2021, CHPA’s CMD Committee proposed an initial list of questions and answers for FDA’s consideration based on existing guidance which served as the foundation for the webpage. In August, the page was published as a list of frequently asked questions (FAQ) that includes topics such as how to design OTC devices, ways to conduct human factor testing, and bringing novel OTC devices to market. 

At CHPA’s recent Regulatory, Quality & Scientific Conference (RSQ), Dr. Jonette Foy, deputy office director at the FDA Center for Devices and Radiological Health (CDRH) Office of Policy said, “I wanted to thank CHPA for their initiative and facilitation in helping to identify initial areas of interest.” Dr. Foy recognized that “putting a guidance out was not an option” due to the time and resources available. As an alternative approach, FDA “captured and consolidated pieces of information that already existed via different policy documents [to] create an FAQ.” Dr. Foy concluded, “by putting this information in the public domain, we hope it will help to develop more medical devices which can be appropriately used as OTC devices.”

“The OTC devices webpage is just a start, but it’s a great hub for companies doing initial research on compliance information; we are pleased that FDA is open to updating the information on the page,” says Dr. Howard. “Not only does it pull through what FDA has already issued regarding OTC devices, it will help us identify where other guidance might be needed, as well.”

The Consumer Healthcare Products Association (CHPA), founded in 1881, is the national trade association representing the leading manufacturers and marketers of consumer healthcare products, including over-the-counter (OTC) medicines, dietary supplements, and consumer medical devices. CHPA is committed to empowering self-care by ensuring that Americans have access to products they can count on to be reliable, affordable, and convenient, while also delivering new and better ways to get and stay healthy. Visit www.chpa.org.