|Topic:||Safe Medical Devices for Children|
THE NATIONAL ACADEMIES
Institute of Medicine
Board on Health Sciences Policy
Committee on Postmarket Surveillance of Pediatric Medical Devices
Monday, July 11, 2005
2125 Rayburn House Office Bldg. -- 2:30 p.m.
Tuesday, July 12, 2005
135 Hart Senate Office Bldg. -- 10:00 a.m.
428 Dirksen Senate Office Bldg. -- 11:00 a.m.
Safe Medical Devices for Children
Requested by Congress in P.L. 107-250, Safe Medical Devices for Children, evaluates the Food and Drug Administration's (FDA’s) postmarket surveillance of medical devices used with children specifically. The report found that FDA lacks effective procedures to monitor the status of safety studies of medical devices and that it was difficult to reliably identify postmarket studies that considered pediatric issues or focused on children and recommended some specific remedial steps.
These series of briefings were for members of Congress and congress staff only. The report was publicly released on July 18, 2005 and can be found, in its entirety, on the Web site of the National Academies Press.