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

Working Group Chair(s)
Danica Marinac-Dabic
Food and Drug Administration (FDA)
United States of America
Membership
Regulator and stakeholder membership
Status
Work completed

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.

Participants

Stephen Graves
University of Adelaide

Márcia Cristina de Moraes Reis Ribeiro
Brazilian Health Regulatory Agency (ANVISA)
Maria Gloria Vicente
Brazilian Health Regulatory Agency (ANVISA)

Patrick Fandja
Health Canada
Rana Filfil
Health Canada

Andrew Crosbie
MHRA - UK
Gerold Labek
Innsbruck Medical University
Paul Piscoi
European Commission
Richard Armstrong
Northgate Information Solutions UK
Rob Nelissen
Leiden University Medical Center (LUMC)
Tom Melvin
Health Products Regulatory Authority (HPRA), Ireland

Dr Madoka Murakami
Pharmaceuticals and Medical Devices Agency (PMDA)
Kazuaki Sekiguchi
JFMDA
Kazuhiro Sase
Juntendo University
Nobuhiro Handa
Pharmaceuticals and Medical Devices Agency (PMDA)
Seiko Usami
Pharmaceuticals and Medical Devices Agency (PMDA)

Amiran Preobragensky
Federal Service for Surveillance in Healthcare (Roszdravnadzor)
Aysylu Valeeva
Federal Service for Surveillance in Healthcare
Denis Sharikadze
Federal Service for Surveillance in Healthcare (Roszdravnadzor)
Sergey Novikov
Federal Service for Surveillance in Healthcare (Roszdravnadzor)

Art Sedrakyan
Weill Cornell University
Danica Marinac-Dabic
Food and Drug Administration (FDA)
James Tcheng
Duke University
Nicole Jones
Food and Drug Administration (FDA)
Sharon-Lise Normand
Harvard Medical School