Navigation Links
FDA Awards Three Grants Designed to Stimulate Development of Pediatric Medical Devices
Date:9/21/2009

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.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

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

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
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Corbett Selected to Host the Only Midwest Global Awards Judging Competition
2. Good Clinical Practice Journal Awards: Winners Announced
3. NIH awards $10.8M to Columbia to study connection between diabetes and heart disease
4. NIH awards Einstein multimillion dollar grant to extend studies of exceptional longevity
5. 2007 EURYI: 20 researchers to receive Nobel Prize-sized awards in Helsinki
6. HRET Awards Four Health Career Scholarships
7. Portico Systems Wins Three Awards in 30 Days
8. Kensey Nash Reports Acceleration of Stock Awards Triggered by Shareholder Acquisition of Greater Than 20% of Outstanding Shares
9. Bioniche Food Safety Vaccine Receives Global Top Honours in Industry Excellence Awards
10. The Sisters of Charity Health System Awards Four Nursing Scholarships in Ohio and South Carolina
11. U.S. Labor Department Awards $10.1 Million for Safety and Health Training Grants
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... Montreal, Canada (PRWEB) , ... June 25, 2016 , ... ... the pursuit of success. In terms of the latter, setting the bar too high ... low, risk more than just slow progress toward their goal. , Research from ...
(Date:6/24/2016)... ... 2016 , ... June 19, 2016 is World Sickle Cell Observance Day. In ... benefits of holistic treatments, Serenity Recovery Center of Marne, Michigan, has issued ... Sickle Cell Disease (SCD) is a disorder of the red blood cells, which can ...
(Date:6/24/2016)... MIAMI, Fla. (PRWEB) , ... June 24, 2016 , ... ... Florida Trend magazine’s 2016 Legal Elite. The attorneys chosen by their peers for this ... of Florida. , Seven Greenberg Traurig Shareholders received special honors as members of this ...
(Date:6/24/2016)... ... ... Inc, makers of Topricin and MyPainAway Pain Relief Products, join The ‘Business for a Fair ... hour by 2020 and then adjusting it yearly to increase at the same rate as ... the wage floor does not erode again, and make future increases more predictable. , The ...
(Date:6/24/2016)... NY (PRWEB) , ... June 24, 2016 , ... ... Haute Living, is proud to recognize Dr. Barry M. Weintraub as a prominent ... “the most beautiful women in the world, and the most handsome men, look ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... --  Pulmatrix, Inc ., (NASDAQ: PULM ), ... today that it was added to the Russell Microcap ... set of U.S. and global equity indexes on June ... for Pulmatrix," said Chief Executive Officer Robert Clarke ... in developing drugs for crucial unmet medical needs, and ...
(Date:6/23/2016)... June 23, 2016  MedSource announced today that ... e-clinical software solution of choice.  This latest decision ... value to their clients by offering a state-of-the-art ... relationship establishes nowEDC as the EDC platform of ... full-service clients.  "nowEDC has long been a preferred ...
(Date:6/23/2016)... , June 23, 2016 Research ... "Pharmaceutical Excipients Market by Type (Organic Chemical (Sugar, Petrochemical, ... (Oral, Topical, Coating, Parenteral) - Global Forecast to 2021" ... The global pharmaceutical excipients market is ... a CAGR of 6.1% in the forecast period 2016 ...
Breaking Medicine Technology: