Why did a lot of orthotists stop making cranial remolding orthosis in the last few years?
In 1998 the FDA ruled that cranial remolding orthosis fell into the category of Class 2 medical devices and required strict control standards. In order to continue providing these orthosis, centers had to apply for and receive FDA 510(k) clearance, which is an expensive and labor intensive process. Many orthotists stopped providing orthosis at that point because their cranial remolding orthosis design had not gone through the process of being cleared by the FDA.
