- Draft Guidance for HDE Holders
- Institutional Review Boards (IRBs) Clinical Investigators and FDA Staff
- Humanitarian Device Exemption (HDE) Regulation
- "Premarket Assessment of Pediatric Medical Devices"
- "Guidance for Industry and Staff: Pediatric Expertise for Advisory panels"
Related Links:
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FDA sent a report to the Congressional Committee in March of 2008 regarding the effect of the Pediatric Medical Device Safety and Improvement Act on the device industry.
Here is a link to the report to Congress
Institute of Medicine Report
Safe Medical Devices for Children
Released July 18, 2005
http://www.iom.edu/CMS/3740/18614/28277.aspx
FDA Pediatric Medical Devices Science and Research
www.fda.gov/ScienceResearch/SpecialTopics/PediatricTherapeuticsResearch/default.htm
Should your child be in a clinical trial? http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048699.htm
CDRH Learn http://www.fda.gov/Training/CDRHLearn/default.htm
MedSun (kidNet) Information http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/ucm112683.htm