The FDA Office of Orphan Products Development (OOPD) posted grant notice (RFA-FD-09-007) on April 30th to solicit grant applications from nonprofit organizations to develop, produce, and distribute pediatric medical devices. Although administered by OOPD, this grant program encompasses devices that could be used in all pediatric conditions and diseases—not just rare diseases. The pediatric population includes patients who are 21 years of age or younger at the time of diagnosis or treatment.
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 size, growth, and body chemistry, and this adds to the challenge in developing pediatric devices.
To help remedy this problem, the Pediatric Medical Device Safety and Improvement Act of 2007, established the Pediatric Device Consortia Grant Program (P50) to support non-profit work on stimulating projects. This will help promote pediatric device development since interdisciplinary researchers would be able to focus on common problems. The P50 grant mechanism supports a wide spectrum of activities.
The goal is to encourage development, production, and distribution of medical devices by:
- Encouraging innovation and work to connect individuals with potential manufacturers
- Mentoring and managing device projects through the development process
- Connecting innovators and physicians to existing Federal and non-Federal resources
- Addressing the scientific and medical merit of proposed pediatric device projects
- Providing help with business development, personnel training, prototype development, post-market needs, and other activities
OOPD is coordinating the grant program with NIH. The funding is expected to be for $2 million, to be distributed on a competitive basis, and result in one to four awards. The grant application is due on June 15, 2009.
Go to www.grants.gov for further information. For more information from FDA’s OOPD, email Linda.Ulrich@fda.hhs.gov or call 301-827-3666.