1. Radiological Devices Advisory Committee Meeting November 18, 2009 John A. DeLucia iCAD, Inc.

2. 2 Comments CAD Guidance Informed Consent for Image Collection

3. 3 CAD Guidance – General Comments We welcome the efforts of FDA in issuing this guidance –Catalyst for change –CAD manufacturers experiencing gridlock in FDA review of submissions –iCAD has experienced unreasonable delays in our submissions –New products and improvements are not getting to market and our patients in timely manner Areas of Concern –The new CAD guidance only addresses new or significantly modified 510(k) CAD devices and not Class III CAD devices –Lacks a robust testing and submission paradigm

4. 4 CAD Guidance – 510(k) CAD Devices The new CAD guidance 1 presents examples where modifications to cleared 510(k) CAD devices may result in new submissions –Focus on testing & clinical considerations and device classification FDA should reference an existing guidance document in the new CAD Guidance – “Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1) January 10, 1997” Detailed flowchart to assess modifications to 510k devices The 510(k) holder is best qualified to make this assessment 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 Draft Guidance for Industry and FDA Staff: Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)]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

5. 5 CAD Guidance – Class III CAD Devices No guidance (paradigm) on when to submit a PMA supplement for Class III devices as there is for 510(k) devices The guidance does not answer key concerns of Class III CAD manufacturers: –How to handle incremental changes to Class III CAD devices? E.g. Modification to a mammographic CAD software interface to accept new digital (DR/CR) images with no change to CAD algorithm

6. 6 CAD Guidance – Class III CAD Devices –For approved CAD devices that do not have reader studies, is standalone testing still acceptable for incremental changes? –For approved CAD devices with valid reader studies, when do incremental performance changes, demonstrated through standalone testing, trigger another reader study? Industry needs a clear paradigm issued in a timely manner to move forward

7. 7 Sample Testing Paradigm for Approved Class III CAD Devices Type of Change/Risk Verification Testing Standalone Testing Reader Study Workflow/LowX Software Interface/Moderate XX Core Algorithm/High XXX Industry Needs a Testing Paradigm Based on Science, Safety, and Efficacy And Proportional To the Type of Change

8. 8 Informed Consent FDA's Investigational Device Regulations are intended to encourage the development of new, useful devices Image collection is critical to CAD development –Development, training and testing of the software algorithm There are two types of image collection: –Retrospective – data acquired from existing or historical clinical case records –Prospective – data acquired concurrently during patient evaluation & treatment

9. 9 Informed Consent FDA has consistently maintained that: –There are no exceptions from the informed consent requirements on the grounds that specimens are not identifiable, AND –FDA regulations do not allow IRBs to decide whether or not to waive informed consent iCAD believes that informed consent should be waived for de-identified retrospective data collection –No/little patient risk, no adverse affect to patient health information, impractical to collect informed consent –Least Burdensome approach –Further, in our experience there is significant confusion amongst IRBs on this issue FDA should seriously consider exercising enforcement discretion as to the informed consent requirements for de-identified retrospective image collection as they do with in-vitro diagnostic leftover specimens 1 1.“Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable”

10. 10 Summary New Guidance –We need clear/concise guidance for all CAD devices whether new or modified –Acceptable Clinical Testing & Regulatory Submission Paradigm Informed Consent –FDA should exercise enforcement discretion for informed consent requirements during de-identified retrospective image collection

11. 11 Thank you