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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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radiological devices advisory committee meeting

Radiological Devices Advisory Committee Meeting

November 18, 2009

John A. DeLucia

iCAD, Inc.

  • CAD Guidance
  • Informed Consent for Image Collection
cad guidance general comments
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
cad guidance 510 k cad devices
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 Draft Guidance for Industry and FDA Staff: Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)]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

cad guidance class iii cad devices
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
cad guidance class iii cad devices1
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
sample testing paradigm for approved class iii cad devices
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

informed consent
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
informed consent1
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”

  • 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