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)

• This topic was modified 11 months, 3 weeks ago by Saa Kosiri.
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