CPAP machines, masks, and humidifiers are classified and regulated by the FDA as Class II medical devices. This means a valid prescription is required for a legal sale of these devices to take place.
Prescriptions are not required for other PAP accessories such as filters, mask parts, non-heated tubing, and other external accessories.
To view further information about the Federal regulations, please visit the American Academy of Sleep Medicine website or the federalregister.gov.