Awardees will work with industry and the FDA to address unmet pediatric device needs
WASHINGTON, Sept. 21 /PRNewswire-USNewswire/ -- 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.
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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:
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:
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
http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/WhomtoContactaboutOrphanProductDevelopment/ucm134337.htm
The Pediatric Device Consortia Grant Program Fact Sheet
http://www.fda.gov/downloads/ForIndustry/DevelopingProductsforRareDiseasesConditions/WhomtoContactaboutOrphanProductDevelopment/UCM162433.pdf
The FDA’s Center for Devices and Radiological Health Web site on Pediatric Devices
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ucm135104.htm
The FDA’s Office of Orphan Products Development Web site
http://www.fda.gov/AboutFDA/CentersOffices/OC/OfficeofScientificandMedicalPrograms/OfficeofScienceandHealthCoordination/OfficeofOrphanProductDevelopment/default.htm
Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
SOURCE U.S. Food and Drug Administration
CONTACT: Peper Long of FDA, +1-301-796-4671, mary.long@fda.hhs.gov
Web site: http://www.fda.gov//
