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Food and
Drug Administration
FDA Radiological Devices Panel Meeting
March 4 - 5, 2008
BRIEFING INFORMATION
Day 1: March 4, 2008
FDA
Disclaimer
Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C §552). These redacted portions will appear as a white space on the screen or on the printed page
FDA Radiological Devices Panel Meeting Briefing Package
(pdf)
FDA Radiological Devices Panel Meeting DRAFT discussion questions – Draft discussion questions for Mammography CAD devices (pdf)
Reader Study Spreadsheet Sequential Studies
(pdf)
Reader Study Historical Control Studies
(pdf)
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Day 2: March 5, 2008
FDA Radiological Devices Panel Meeting
March 5, 2008
Briefing Information
FDA Radiological Devices Panel Meeting DRAFT discussion questions – Draft discussion questions for Lung CAD devices
( pdf)