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FDA NEWS RELEASE

For Immediate Release: Sept. 21, 2009

Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Awards Three Grants Designed to Stimulate Development of Pediatric Medical Devices
Awardees will work with industry and the FDA to address unmet pediatric device needs

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

A panel of six experts with experience in medicine, business, and device development reviewed 16 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 the Michigan Pediatric Device Consortium, $1 million
  • Pedro DelNido, M.D., and the Pediatric Cardiovascular Device Consortium, $500,000
  • Michael Harrison, M.D., and the University of California at San Francisco Pediatric Device Consortium, $500,000.

Development of medical devices for children lags up to a decade behind similar devices intended for use 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.

“Congress provided the FDA with this funding so that we could help connect innovators and their ideas with experienced professionals who assist them through development” said Timothy Cote, director of the FDA’s Office of Orphan Product Development. “These grants will strengthen public health by spurring the development of medical devices that safely and effectively meet the special and unique needs of our children.”

Medical device legislation passed by Congress in 2007 established funding to be distributed as grants for nonprofit groups to help stimulate projects to promote the development and availability of pediatric devices. 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.

For more information:

FDA’s Web site on Pediatric Device Consortia Grant Program

The Pediatric Device Consortia Grant Program Fact Sheet

The FDA’s Center for Devices and Radiological Health Web site on Pediatric Devices

The FDA’s Office of Orphan Products Development Web site

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