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FDA NEWS RELEASE

For Immediate Release: Oct. 3, 2011
Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA awards three grants to stimulate development of pediatric medical devices
Grantees will work with industry and the FDA to address unmet pediatric device needs

The U.S. Food and Drug Administration today announced the awards of three grants to boost the development and availability of medical devices for children.

A panel of five experts with experience in medicine, business, and device development reviewed 10 applications for the grants, which will be administered by the FDA’s Office of Orphan Products Development. The recipients and grant amounts include:

• James Geiger, M.D. and Andre Muelenaer, M.D. of the University of Michigan Pediatric Device Consortium and the Pediatric Medical Device Institute Pediatric Medical Device Consortium, $1.1 million a year for two years.
• Michael Harrison, M.D. and the University of California, San Francisco Pediatric Device Consortium, $500,000 a year for two years.
• Barbara Boyan, Ph.D. and the Atlanta Pediatric Consortium, $900,000 a year for two years.

“Congress provides FDA with this funding so that we can help connect innovators and their ideas to experienced professionals who can assist them through development,” said Debra Lewis, O.D., acting director of the FDA’s Office of Orphan Product Development. “Development of medical devices for children lags up to a decade behind similar devices used in adults.”

Children differ in terms of size, growth, and body chemistry and present unique challenges to device designers. In addition, the activity level and ability to manage some implantable or long-term devices may vary greatly among children. While this program is administered by the Office of Orphan Products Development, it is intended to encompass devices used in all pediatric diseases, not just rare diseases.

Legislation passed by Congress in 2007 established funding for grants to nonprofit groups to help stimulate projects to promote the development and availability of pediatric medical devices. These grants are meant to encourage the development of multiple pediatric device projects. While a small portion of the grants fund specific projects, the real spirit of this grant program is to provide information clearinghouses to promote multiple projects.

This is the second round of this type of biennial grants to be awarded. Those receiving these grants will:

• encourage innovation and connect qualified individuals with good pediatric device ideas to potential manufacturers
• mentor and manage pediatric device projects through their development, including prototype design and marketing
• connect innovators and physicians to existing federal and non-federal resources
• assess the scientific and medical merit of proposed pediatric projects and provide assistance and advice on business development, training, prototype development and post-marketing needs.

As part of the legislation, each of the grant recipients will coordinate among the FDA, device companies, and the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development to facilitate research and any necessary applications for device approval or clearance.

Past grant awardees have assisted in the development of devices to treat scoliosis, pediatric valvular heart disease, and projectile vomiting in newborns, among other diseases.

For more information:

Pediatric Device Consortia Grant Program

Pediatric Device Consortia Grant Program Fact Sheet

FDA Center for Devices and Radiological Health: Pediatric Medical Devices

FDA: Developing Products for Rare Diseases and Conditions

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