Regulation of Consumer Medical Devices
The term “consumer medical device (CMD)” (i.e., Class I and Class II medical devices) refers to consumer-facing devices that are sold over-the-counter (OTC) at non-specialty retail locations, including drug stores, grocery stores, convenience stores, and online. CMDs are not sold by prescription only or distributed and used exclusively in health care settings. CMDs have established safety profiles and are for use by consumers in non-clinical environments. Generally, no training is necessary to use a CMD. Rather, these devices are sufficiently user-friendly to be used by laypersons without training. 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.
In keeping with the U.S. FDA’s mission, the Center for Devices and Radiological Health (CDRH) is responsible for protecting and promoting public health. They work to assure that patients and healthcare providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. Additionally, FDA provides consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. They also facilitate medical device innovation by advancing regulatory science, providing the industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.
The Food and Drug Administration (FDA) assures that patients and health care providers have timely and continued access to safe, effective, and high-quality medical devices. In addition, it provides consumers, patients, caregivers, and healthcare providers with understandable and accessible science-based information about the products it oversees.
In order to understand medical devices, it is important to understand what a medical device is and how the FDA classifies medical devices.