Expert urges FDA to create "pediatric ombudsman" within CDRH

12/29/2009 | Clinica (subscription required)

The FDA's Center for Devices and Radiological Health should include the position of "pediatric ombudsman" to assist companies seeking regulatory approval for children's medical devices, said Tara Federici, an official for industry trade group the Advanced Medical Technology Association. The recommendation is in response to the agency's call for comments on device clinical studies in children.

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