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Pediatric Medical Development & FDA Approvals

As a result of an almost complete lack of reliable data on the use of medical devices in children, the 2007 FDA Amendments Act (FDAAA) authorized grants to assist in the development of pediatric devices. In this December 2011 report, "Pediatric Medical Devices: Provisions Support Development, but Better Data Needed for Required Reporting," the Government Accountability Office takes a hard look at the progress made to date, describing barriers to developing these devices, the developments made possible by the grants, and examining FDA's data on the pediatric devices approved since FDAAA was enacted. Finally, the report includes recommendations for improvements needed at FDA and FDA's responses to GAO comments.

Document Number: 5246385A

Usual price -- $107.95
Free through February 10