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Integrating patient registries and innovative tools for enhanced medical device evaluation and tracking

Registries of patients undergoing medical device procedures represent a growing potential electronic resource for local and global medical device evaluation and tracking. To integrate such established data resources with new tools (such as UDIs) and optimize their regulatory applications, shared essential principles of informatics infrastructure and best epidemiologic and statistical analytic methodologies could enhance the quality, speed and cost-efficiencies of regulatory science for medical devices. Therefore, the purpose of this Work Item is to collaboratively develop a shared set of those essential principles. 'Essential principles' in the scope of this work are intended to encourage consistency and transparency across global efforts without prescribing them as 'required' in any way.

Working Group Chair: Danica Marinac-Dabic, USA contact Danica Marinac-Dabic

Working Group Membership: Regulator and stakeholder membership

Regulatory Members


  • Marcia Cristina de Moraes Reis Ribeiro
  • Maria da Gloria Vicente


  • Rana Filfil, PhD
    Health Canada
  • Patrick Fandja
    Health Canada


  • TBD
    State Food and Drug Administration

European Union

  • Paul Piscoi, MD
    European Commission
  • Andrew Crosbie, PhD
    MHRA - UK
  • Tom Melvin
    HPRA -Ireland


  • Nobuhiro Handa, MD, PhD
  • Seiko Usami, PhD
  • Madoka Murakami, PhD


  • Aysylu Valeeva
    Roszdravnadzor, Russian Federation
  • Amiran Preobragensky
    Roszdravnadzor, Russian Federation
  • Denis Sharikadze
    Roszdravnadzor, Russian Federation
  • Sergey Novikov
    Roszdravnadzor, Russian Federation

United States

  • Danica Marinac-Dabic, MD, PhD
    US FDA
  • Nicole Jones
    US FDA

Non-Regulatory Members


  • Stephen E. Graves, M.B.B.S. PhD FRACS FA
    University of Adelaide University of Adelaide

European Union

  • Gerold Labek, MD
    Innsbruck Medical University
  • Rob G.H.H. Nelissen, M.D. Ph.D
    Leiden University Medical Center (LUMC)
  • Richard Armstrong
    Northgate Information Solutions UK


  • Kazuhiro Sase, MD, PhD
    Juntendo University
  • Kazuaki Sekiguchi, PhD

United States

  • Art Sedrakyan, MD, PhD
    Weill Cornell University
  • James Tcheng, MD, FACC, FSCAI, FESC US
    Duke University
  • Sharon-Lise Normand, PhD
    Harvard Medical School