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Expert Rev Med Devices. 2009 Mar;6(2):131-5. doi: 10.1586/17434440.6.2.131.

Device safety and effectiveness in the pediatric population: a US FDA perspective.

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Division of Anesthesiology, General Hospital, Infection Control and Dental Devices, Center for Devices and Radiological Health, Office of Device Evaluation, FDA, Rockville, MD 20857, USA.


The US FDA recognizes that there are many challenges to ensuring that medical devices are used responsibly and safely in the pediatric population. Education plays a key role, and manufacturers and healthcare providers must be informed of medical device issues unique to the pediatric population. Healthcare workers and device manufacturers must recognize that adverse events may differ between the adult and pediatric population and among pediatric subpopulations. Risk mitigation may also differ, and heightened awareness will reduce the potential for adverse events and promote the safe use of medical devices in children.

[Indexed for MEDLINE]

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