FDA Device Approval–What You Were Not Taught in Training Current Concept Review

Abstract

Medical devices are ubiquitous in the practice of pediatric orthopaedic surgery, but few surgeons receive any formal training or education on the process of bringing a medical device to market for pediatric orthopaedic patients. Innovation in the field of medical devices has led to significant improvement in the care of pediatric orthopaedic patients.

Understanding the history, structure, and pathways to market approval is critical to encouraging innovation of novel devices and techniques and improving the care of pediatric orthopaedic patients. Orthopaedists should have a command of the concepts of adverse event reporting as well as an understanding of the on and off-label uses of medical devices as this is helpful for discussion of care and informed consent for the use of such devices.

Due to the relative rarity of the diseases addressed, pediatric orthopaedists should understand the framework of the humanitarian device exemption as well. These concepts can be synergized into some successful improvement in care for pediatric orthopaedic patients. One such success story in recent history was the introduction of the vertical expandable titanium prosthetic rib (VEPTR) system by Dr. Robert Campell. The American Academy of Orthopaedic Surgeons (AAOS) and Pediatric Orthopaedic Society of North America (POSNA) recognize the importance of making innovative medical devices available to pediatric patients and have made advocacy an important aspect of their mission and relationship with industry and governmental regulatory organizations.