• Decrease
  • Normal
  • Increase
U.S. Department of Health and Human Services

About FDA

Summary Report on the Pediatric Device Consortia Grant Program

Description: 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.

Accomplishment: 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.

Briefing Status: COMPLETED

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Convene and assign sections to PDC PO's

6/30/2011

Completed 6/8/2011

B. Complete draft Background/Initial Grant Awards

7/29/2011

Completed 7/22/2011

C. Complete draft Summaries of Consortia

8/31/2011

Completed 8/31/2011

D. Complete Assessing the Program's First Cycle/Next Steps

10/31/2011

Completed 10/31/2011

E. Complete Final Report

11/15/2011

Completed 11/14/2011

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.