FDAnews
www.fdanews.com/articles/89877-new-bill-encourages-development-of-pediatric-devices

NEW BILL ENCOURAGES DEVELOPMENT OF PEDIATRIC DEVICES

December 8, 2006

Sens. Chris Dodd (D-Conn.) and Mike DeWine (R-Ohio) introduced a bill to promote the development and use of medical devices designed for young children so physicians have choices over "one-size-fits-all" products.

The "Pediatric Medical Device Safety and Improvement Act of 2006" improves incentives to design devices for children and preserves the safety system for the new products, the senators said in a Dec. 7 statement. The bill will offer assistance to designers, streamline regulatory procedures and promote pediatric device issues at the FDA and the NIH, they added.

Medical devices designed for children's smaller bodies can lag five or 10 years behind those designed for adults, according to the senators.

"Because the pediatric market is so small and pediatric diseases [are] relatively rare, there has been little incentive for device manufacturers to focus their attention on children," Dodd said. He compared the issue to when children were given reduced doses of drugs meant for adults, and did not have drugs designed with them in mind.

The Senate referred the bill to the committee on Health, Education, Labor and Pensions.