Home Forums Quarterly Meetings Quarterly Meetings 2003 – 2020 2017 Fall 2017 Fall Educational Meeting Materials

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      AvatarKatherine Sale
      Keymaster

      Attached documents:
      2017 OSMA Fall Educational Meeting Minutes
      – Attachment 01 2017 OSMA Fall Educational Meeting Presentation (morning)
      – Attachment 02 2017 OSMA Fall Educational Meeting Presentation (afternoon)
      – Attachment 03 Attendee List
      Guest Presentations:
      -ODE Update (Constance Soves, Ph.D.)
      -DOD Overview (Kate Kavlock, Ph.D.)
      -Case for Quality (Vesa Vuniqi, Francisco Vicenty)
      -Image Recognition Software Initiatives Being Evaluated as Alternatives to the UDI Process (Anton Dmitriev)
      -Endotoxin Update (Ronald Jean, Melissa Hall)
      -FDA’s New Initiatives with Field Program Alignment (William MacFarland)
      -Office of Compliance Update (Matthew Krueger)
      -Results of OSMA’s FDA Performance Survey (Ryan Massey)
      Discussion of Spine-Related Topics
      -510(k) Review Process for Spinal Devices (Melissa Hall, Ronald Jean, Ph.D.)
      -Intervertebral Body Fusion Device Indications for Use (Vincent Devlin, M.D.)
      -ORCA Orthopedic Rapid Comparative Analysis (Jonathan Peck)
      *Refer to the minutes for a synopsis of the Table Topic Discussions – Factors Contributing to Design/Testing/Regulatory Delays (Melissa Hall/Ronald Jean), Perspectives on Role and Importance of Spinal Device Labeling (Stephanie Bechtold) and Potential Future Areas of Focus for Spinal Devices (Colin O’Neill)

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