Pediatric Device Consortia Grant Program (P50)

Food and Drug Administration

Description

Purpose The development of pediatric medical devices currently lags five to ten years behind the development of devices for adults. Children differ from adults in terms of their size, growth, development, and body chemistry, adding to the challenges of pediatric device development. There currently exists a great need for medical devices designed specifically with children in mind. Such needs include the original development of pediatric medical devices, as well as the specific adaptation of existing adult devices for children. Thus, as part of the 2007 FDAAA legislation, Congress passed the Pediatric Medical Device Safety and Improvement Act of 2007. Section 305 of this Act requires the Secretary to provide demonstration grants or contracts to nonprofit consortia to promote pediatric device development. The FDA definition of “pediatric” devices, for purposes of device development, refers to devices intended to be used for patients who are 21 years of age or younger at time of diagnosis or treatment. The FDA’s Center for Devices and Radiologic Health defines “pediatric use” as any use of a medical device in a pediatric population in which there is a primary pediatric indication OR a more general indication where significant pediatric application is anticipated. Research Objectives The goal of FDA's Pediatric Device Consortia Grant Program is to support nonprofit consortia in stimulating projects which will promote pediatric device development. The consortia will facilitate the development, production, and distribution of pediatric medical devices by 1) encouraging innovation and connecting qualified individuals with pediatric device ideas with potential manufacturers; 2) mentoring and managing pediatric device projects through the development process, including product identification, prototype design, device development, and marketing; 3) connecting innovators and physicians to existing Federal and non-Federal resources; 4) assessing the scientific and medical merit of proposed pediatric device projects; and 5) providing assistance and advice as needed on business development, personnel training, prototype development, and post-marketing needs. See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Who can apply

• State governments
• County governments
• City or township governments
• Special district governments
• Public and State controlled institutions of higher education
• Native American tribal governments (Federally recognized)
• Public housing authorities / Indian housing authorities
• Native American tribal organizations (other than Federally recognized)
• Nonprofits with 501(c)(3) status (other than higher education)
• Nonprofits without 501(c)(3) status (other than higher education)
• Private institutions of higher education
• Others

Contact

Marc Pitts <br/>FDA - Electronic Integration Liaison <br/>Phone: 301-827-7162
marc.pitts@fda.hhs.gov