Radiological Devices Advisory Committee Meeting

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

2. Comments • CAD Guidance • Informed Consent for Image Collection

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 ourpatients 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. CAD Guidance – 510(k) CAD Devices • The new CAD guidance1 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 Draft Guidance for Industry and FDA Staff: Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)]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. 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. 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. Sample Testing Paradigmfor Approved Class III CAD Devices Industry Needs a Testing Paradigm Based on Science, Safety, and Efficacy And Proportional To the Type of Change

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. 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 specimens1 1. “Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable”

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. Thank you