Dodd Reintroduces Legislation on Medical Devices for Children

Sen. Chris Dodd (D-Conn.) reintroduced a bill to improve incentives for developing pediatric medical devices so children are not left with "one-size-fits-all" products.

The "Pediatric Medical Device Safety and Improvement Act of 2007," S.830, would offer assistance to devicemakers, streamline regulatory procedures and promote pediatric issues at the FDA and the NIH, Dodd said. Specifically, the legislation would:

Modify the humanitarian device exemption (HDE) for medical devices to allow profit for HDE devices specifically designed for children. No profit would be allowed for a device used in more than 4,000 individuals;

Establish a mechanism for the FDA to track the number and types of devices approved specifically for children or for pediatric conditions, as well as the approval times for premarket applications and HDEs;

Require the NIH to designate a contact point or office to help devicemakers and physicians access funding for pediatric device development;

Establish demonstration grants for nonprofit consortia to promote pediatric device development, including "matchmaking" between inventors and manufacturers and connecting innovators and physicians to federal resources;

Grant explicit authority to the FDA's Pediatric Advisory Committee to monitor pediatric devices and make recommendations for improving their availability and safety; and

Incorporate several recommendations of the Institute of Medicine, including improving the postmarket surveillance of medical devices for children and expanding public access to postmarket studies of these devices.

Reps. Ed Markey (D-Mass.) and Mike Rogers (R-Mich.) introduced companion legislation in the House.

( http://www.fdanews.com/ddl/34_12/ )