Food and Drug Administration regulation of orthotic cranioplasty

Objective: To present information regarding the current federal regulation of cranial orthotics used for the treatment of deformational plagiocephaly as well as to discuss concerns raised by the Food and Drug Administration regarding the safety and effectiveness of these devices. Background: Although first introduced in 1979, the use of orthotic helmets for the treatment of deformational plagiocephaly was slow to gain acceptance. However, with the recent increase in infants presenting with this condition, numerous orthotic treatment programs have been established throughout the country. Until recently, federal regulation of this "industry" was largely ignored. Regulation: In 1995 our office was served notice that our orthosis would require clearance from the FDA, Since the FDA had never approved a medical device of this kind, clearance presented a significant challenge. However, after 3 years of providing clinical data, clearance was finally granted, and a new device category known generically as "cranial orthosis" was created. A cranial orthosis is considered to be a Class II neurology device and requires both general and special controls in order to ensure its safety and effectiveness. Summary: Orthotics used for the treatment of deformational plagiocephaly are regulated by the FDA and are considered Class II neurology devices. Submission of a premarket notification (510[k]) is required prior to placing these devices on the market.