Paediatric device development

Article type: Research Article

Authors: Ulrich, Linda C.

Affiliations: Office of Orphan Products Development, OC, FDA, USA. E-mail: [email protected]

Abstract: The development of medical devices for children is probably the next frontier in scientific and regulatory development. While some pediatric devices may have a potentially large market share, many do not and this makes them "orphans" in their own right. Recently the U.S. government has started to pay new attention to the area of pediatric device development. There are several challenges to paediatric device development and as, a consequence, it currently lags 5 to 10 years behind those for adults. Thus, many physicians and surgeons are forced to adapt adult devices in order to suit their paediatric patients. Challenges in paediatric device development reside in the fact that children differ from adults not only in terms of their size, but also because they are growing, so often a static device may not be adequate for a growing child. In addition, after a few months to years, an infant or child may outgrow a device and need a new one.

Keywords: Device, paediatric, FDAAA, HDE

DOI: 10.3233/PPL-2010-0275

Journal: Pharmaceuticals, Policy and Law, vol. 12, no. 1-2, pp. 89-91, 2010