Radiological Devices Advisory Committee Meeting . November 18, 2009 John A. DeLucia iCAD, Inc. Comments. CAD Guidance Informed Consent for Image Collection. CAD Guidance – General Comments. We welcome the efforts of FDA in issuing this guidance Catalyst for change
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November 18, 2009
John A. DeLucia
1. Draft Guidance for Industry and FDA Staff: Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions
Industry Needs a Testing Paradigm Based on Science, Safety, and Efficacy And Proportional To the Type of Change
1. “Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable”