• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

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  • Draft Guidance for Industry and FDA Staff: Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)]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  • Draft Guidance for Industry and FDA Staff: Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology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