SRS Position Statement

Advocacy Committee Position on Pediatric Spinal Devices

• The Scoliosis Research Society believes that there is a significant need for the development of new, innovative devices for treatment of spinal disease of growing children based on the 2005 American Academy of Orthopaedic Surgeons Pediatric Device Use survey of its members.
  
  
• The Scoliosis Research Society recognizes that there are significant development, economic, and regulatory obstacles currently in the United States preventing the development of pediatric devices and restricting their availability to children.
  
  
• The Scoliosis Research Society recognizes that the solutions to the problem of pediatric orthopaedic device innovation and availability are complex, and require advocacy partnerships between physician organizations, the FDA, NIH, members of industry, patient lay organizations, and the U.S. Congress in order to solve these problems.
  
  
• The Scoliosis Research Society endorses a transparent, definable, and affordable regulatory approval process for the introduction of new innovative pediatric orthopaedic devices for the United States.
  
  
• The Scoliosis Research Society endorses incentives, economic or other, for manufacturers to develop innovative pediatric orthopaedic devices such as changes in the Humanitarian Device Exemption law and other novel incentives.
  
  
• The Scoliosis Research Society endorses the United States Institute of Medicine recommendations for development of safe medical devices for children.
  
  
• The Scoliosis Research Society endorses the creation of a national non-profit Pediatric Device Development Consortium to liaison between manufacturers, the Food and Drug Administration, and the Secretary of Health, and to serve as an advocate for inventors of innovative pediatric orthopaedic devices