Pediatric Device Legislation

Some good news is that significant governmental attention has been given to this issue over the last 5 years.  Special legislation has been enacted to help support the development of medical devices for the unmet pediatric needs.  A report from the FDA was presented to Congress in October 2004.  The report is entitled: ‘Barriers to the Availability of Medical Devices Intended for the Treatment or Diagnosis of Diseases and Conditions that Affect Children’.  What follows are excerpts from that report.

Development costs for pediatric devices are prohibitive — The majority of commenter’s representing all groups indicated that the cost of developing pediatric medical devices is the most significant barrier to the development of new pediatric medical devices. The economic challenges noted include not only the limited size of the pediatric device market, but also that the return on the investment required to develop and test pediatric devices usually falls below the profit goals of most medical device companies.

Based in part on the strength of that report, congress passed the FDA Amendments Act in September of 2007.  This legislation included Title III: Pediatric Medical Device Safety and Improvement Act, which requires that an application or protocol submitted to the FDA for a medical device must include a description of any pediatric subpopulations that suffer from the condition the device will treat, diagnose, or cure. The legislation intends to ensure that pediatric studies and availability of quality product data are considered in new product labeling to ensure pediatric safety and emerging safety issues that occur once a product is used in broad pediatric populations.

“Children deserve access to devices that are safe, effective, and made just for them. Yet today many devices are not made with these considerations in mind, and some necessary devices are not made at all.”  Testimony of Dr. Robert M. Campbell to the U.S. Senate, March 27,2007

The American Academy of Pediatrics supports these legislative efforts and adds ‘Children have specific medical needs that have to be considered when medical and surgical devices are used in pediatric patients. Devices that have not been studied for use in children don’t account for the different needs of children such as allowing for expandable growth, and accommodating their active lifestyles and differing metabolism.’ [Pediatric Drugs and Devices, AAP, 3/07]

The Act also required that the DHHS Secretary submit a plan to congress related to expanding research and efforts related to pediatric device development.  This plan included governmental grant funding to support the development of pediatric devices through pediatric consortiums.  DesignWise Medical has relationships established with these consortia and remains abreast of all government funding opportunities that exist.