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U.S. Department of Health and Human Services

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Standards and Guidance Documents Impacted by the Laboratory for Image Analysis

Working Groups

  • AAPM Working Group: "Computer-aided Diagnosis"

FDA Guidance Documents

  • Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Full-Field Digital Mammography System, November 5, 2010
  • Draft Guidance for Industry and FDA Staff: Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions, October 21, 2009
  • Draft Guidance for Industry and FDA Staff: Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions, October 21, 2009

 

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