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NIH/FDA/AHRQ WORKSHOP ON THE DEVELOPMENT
AND USE OF MEDICAL DEVICES FOR PEDIATRIC
POPULATIONS
Natcher Auditorium, NIH campus in Bethesda,
MD
July 23, 2008
Dear Friends and Colleagues:
The Food and Drug Administration Amendments Act
of 2007, and specifically Title III, the Pediatric
Medical Device Safety and Improvement Act of 2007,
bring the development and use of medical devices
for the pediatric population to national
prominence. While the Federal government has
specific opportunities and responsibilities within
the new law, we are requesting your input and
collaboration in developing a research plan.
An Interagency Workgroup with members from the
Agency for Healthcare Research and Quality, the
Food and Drug Administration and the National
Institutes of Health is planning to hold a
Stakeholders' Public Meeting on July 23rd, 2008 in
Bethesda, Maryland at the Natcher Auditorium on the
campus of the National Institutes of Health (NIH).
The meeting will begin at 8:30 AM (EDT) and
conclude about 5 PM (EDT). The meeting will not be
a formal hearing, but rather an opportunity to
learn and share. There will be no registration
fee. The agenda is still under development, but in
the morning will tentatively include sessions on
legislative background, current status of pediatric
device development, Food and Drug Administration
law, regulations, policy and expectations for
device development and marketing, funding
opportunities from several Health and Human
Services agencies, and expectations and case
studies from academic and commercial developers.
The rest of the day will feature participation in
thematically based discussion groups and an open
plenary discussion with opportunity to provide
direct feedback on important questions and comments
on unmet needs and future directions. The meeting
is an occasion for you to help shape the research
agenda for the development of devices for pediatric
use.
Please hold the date. In the coming weeks, we
plan to provide you with additional information
through a website (address to be sent at a later
time). If you have any preliminary questions, feel
free to contact Steven Hirschfeld, MD, PhD, of the
Eunice Kennedy Shriver National Institute of Child
Health and Human Development, NIH (hirschfs@mail.nih.gov).
Together we can make a difference in the lives
of children.
Kind regards,
HHS Interagency Pediatric Devices Working Group
Planning Committee
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