What is the difference between cranial remolding orthoses and other orthoses such as cervical/spinal orthoses that I can order or fabricate in my own facility?
Most O&P devices are categorized as Class I devices by the Food and Drug Administration (FDA) and are exempt from many regulatory controls. Class II and Class III devices are subject to significant regulatory controls. Since 1998, cranial remolding orthoses have been classified as Class II devices. Only companies that have submitted an application (Form 510(k)) to the FDA and received written FDA clearance to manufacture these devices may fabricate cranial remolding orthoses.
