Under federal law, medical devices are categorized into 3 classes–class I, II, or III- based on their risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness by the Food and Drug Administration (FDA).
CPAP devices are considered a Class II Medical Device, and as such require a prescription for distribution.
There are a few reasons why a prescription is necessary to purchase CPAP and other medical equipment:
Prescriptions come with a set pressure setting based on results of the sleep study. A machine cannot be adequately set without pressure settings. Pressure settings should only ever be determined by a board certified sleep specialist's interpretation of the sleep study.
Without a prescription that includes pressure settings based on the patient's apnea/hypopnea index (AHI) and lowest oxygen saturation (SaO2), patients may not receive the best care. Inadequate settings can be harmful to a patient's health.
For more information, view our Prescription FAQ's