Too few critical medical and surgical devices are designed specifically with children’s needs in mind. To increase the quality and availability of devices made specifically for children, AAP worked with other stakeholders to assess the unmet needs in pediatric device development and marketing. This collaboration led to the passage of the Pediatric Medical Device Safety and Improvement Act of 2007, included in Public Law 110-85.
The Pediatric Medical Device Safety and Improvement Act will increase the tracking of pediatric device approvals by FDA, coordinate the federal response to pediatric device needs, establish a pediatric device research agenda, and strengthen postmarket surveillance of devices used in children. FDA will now be able to require studies longer than 36 months if necessary to assess the safety and effectiveness of devices used in growing children.
The bill also contains two provisions to stimulate pediatric device development. It eliminates the profit restriction on devices approved under the Humanitarian Device Exemption (HDE), and authorizes appropriations for grants to non-profit consortia to facilitate the development, production, approval, and distribution of pediatric medical devices.
Pediatric Medical Device Safety and Improvement Act of 2007
Food and Drug Administration Amendments of 2007