FDA Oversight of Medical Devices

Preface; Medical Devices: FDA Has Met Most Performance Goals but Device Reviews are Taking Longer; Pediatric Medical Devices: Provisions Support Development, but Better Data Needed for Required Reporting; Medical Devices: FDA's Premarket Review & Postmarket Safey Efforts. Testimony of Marcia Crosse, Government Accountability Office delivered at the Hearing on "A Delicate Balance: FDA & the Reform of the Medical Device Approval Process"; Statement of William Maisel, Deputy Director for Science, Center for Devices & Radiological Health, Food & Drug Administration. Hearing on "A Delicate Balance: FDA & the Reform of the Medical Device Approval Process"; Testimony of David Nexon, Senior Executive Vice President, Advanced Medical Technology Association. Hearing on "A Delicate Balance: FDA & the Reform of the Medical Device Approval Process"; Index.