The goal of this report will be to summarize the development and provide an assessment of accomplishments of the Pediatric Device Consortia (PDC) Grant Program in its first two year cycle (September 2009—September 2011). The report will also allow the agency to consider program modifications and next steps for the future. The report will contain an introduction, brief background information on the Pediatric Medical Device Safety and Improvement Act of 2007 and its implementation, a description of the initial grant awards, a description of the four consortia awardees, and an assessment of the program’s accomplishments over the first two years. A review committee will be convened to edit and revise this report. This report is intended for individuals with an interest in the pediatric device consortia grants program. It will be posted on the Office of Orphan Products Development (OOPD) website.The report, entitled, “Pediatric Device Consortia Grants: A Report on the Program’s First Two Years,” summarizes the achievements and challenges during the first two- year cycle of the Pediatric Device Consortia Grant Program and outlines the origins and development of the law that created the program. After passage of the Pediatric Medical Device Safety and Improvement Act of 2007, Congress assigned the FDA’s Office of Orphan Products Development (OOPD) to administer the section of the law calling for the creation of nonprofit consortia that would help stimulate and promote the development and availability of new pediatric medical devices. For many years, the technology of medical and surgical devices for children has lagged behind the comparable devices available for adults. During its initial two-year cycle, the Pediatric Device Consortia Grant Program made significant strides in establishing a new framework of non-profit consortia to encourage innovative concepts and promote the development of new medical devices for children. Four consortia were established initially, and, as of September 2011, more than one hundred pediatric medical devices or device concepts were under development, explored or evaluated with participation from these consortia. COMPLETEDON TRACKA. Convene and assign sections to PDC PO's6/30/2011Completed6/8/2011B. Complete draft Background/Initial Grant Awards7/29/2011Completed7/22/2011C. Complete draft Summaries of Consortia8/31/2011Completed8/31/2011D. Complete Assessing the Program's First Cycle/Next Steps10/31/2011Completed10/31/2011E. Complete Final Report11/15/2011Completed11/14/2011http://www.fda.gov/AboutFDA/Transparency/track/ucm206293.htmFDA-TRACK Office of Special Medical Programs Dashboard