The term "FDA cleared" signifies that the WatchPAT One has undergone a rigorous evaluation process by the U.S. Food and Drug Administration (FDA), which has determined that the device meets the necessary safety and efficacy standards for use in home-based sleep assessments. This clearance indicates that the device has been substantiated through appropriate clinical data to be a reliable tool for diagnosing sleep disorders, such as sleep apnea, in accordance with regulatory guidelines.
Section 510(k) of the Food, Drug, and Cosmetic Act requires device manufacturers who must register to notify the Food and Drug Administration of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification — also called PMN or 510(k). This allows the FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use.