July 23, 2008
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); U.S. Food and Drug Administration (FDA); and Agency for Healthcare Research and Quality (ARHQ)
Natcher Auditorium (Building 45), NIH Main Campus, Bethesda, Maryland
In September 2007, congress passed Title III of the FDA Amendments Act, called the Pediatric Medical Device Safety and Improvement Act, which requires that an applications or protocols submitted to the FDA for a medical device must include a description of any pediatric subpopulations that suffer from the condition the device will treat, diagnose, or cure. The legislation also requires that the DHHS Secretary submit a plan to congress related to expanding research and efforts related to pediatric device development.
This meeting of the Interagency Pediatric Devices Working Group, which includes NIH, AHRQ, and FDA, seeks to elicit feedback, including responses to a Request for Information (RFI), about expanding pediatric device research and development from interested communities and the public to help inform the plan that the DHHS Secretary will submit in accordance with the legislation.
The purpose of this workshop is to:
- Inform the community of the current status of pediatric device development;
- Describe available mechanisms for device product registration;
- Describe available mechanisms for pediatric device project funding;
- Understand what stakeholders’ see to be important areas of study;
- Determine gaps in knowledge and where the needs for research are; and
- Discuss ways to gather the information needed to move ahead, such as overcoming barriers, handling logistics, determining classes of devices to study, and identifying available databases, registries, surveillance systems.
Steven Hirschfeld, M.D., Ph.D., Associate Director for Clinical Research, NICHD
Phone: (301) 496- 3454