Orthotic Devices

Orthotic devices are intended to make the feet more comfortable, minimize stress on the foot, or improve an abnormal or irregular walking pattern. An orthotic device could be a conservative approach to a foot problem, a preventive measure to avoid problems, or a useful support after foot surgery.

According to the American Academy of Orthopaedic Surgeons, orthotic devices commonly used include bunion shield pads, arch pads for people with a flat foot, and heel inserts for people with plantar fasciitis. These devices are sold over-the-counter (OTC) at drugstores and sporting stores. They can be custom made and also sold by podiatrists, physical therapists, or orthotic companies.

Consumers might do well to try a less expensive OTC orthotic device first. "But if the problem doesn't go away after six weeks, you may need to seek a professional consultation and a custom orthotic may be indicated," says Eddy Gosschalk of Southern California Orthotics and Prosthetics. "People who are at risk for developing wounds or who have an unusual foot shape tend to need a custom orthotic." To create a custom orthotic, a plaster cast is taken of your foot and sent to a laboratory.

Most orthotic devices are considered "Class I exempt" by the FDA. This category means they are exempt from pre-market notification requirements. But they still must be manufactured under a quality assurance program, be suitable for intended use, be adequately packaged and properly labeled, and have establishment registration and device-listing forms on file with the FDA. Legally marketed Class I devices are subject to the least regulatory control because they present minimal potential for harm to the user. But when orthotic devices make a new health claim or a claim for certain treatments, or use a fundamentally different technology, they must go through FDA clearance.

Source http://www.fda.gov/fdac/features/2006/206_feet.html