Summary of the FDA virtual public workshop on spinal device clinical review held on September 17, 2021 Article (Web of Science)

cited authors

  • Devlin, Vincent J.; Jean, Ronald; Peat, Capt Raquel; Jiang, Hongying; Anderson, Paul A.; Benson, John C.; Brodke, Darrel S.; Golish, S. Raymond; Kebaish, Khaled M.; Larson, A. Noelle; Serhan, Hassan

publication date

  • September 1, 2022

webpage

published in

category

keywords

  • Adverse events
  • Clinical outcome assessments
  • Clinical study endpoints
  • De Novo Classification request
  • Health disparities
  • Humanitarian device exemption
  • Investigational device exemption
  • Orthopedic devices
  • Premarket approval
  • Premarket notification
  • Secondary surgical procedures
  • Spinal devices
  • Spinal fusion
  • Study enrollment criteria

start page

  • 1423

end page

  • 1433

volume

  • 22

issue

  • 9