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Public Health Effectiveness of the FDA 510(k) Clearance Process Measuring Postmarket Performance and Other Select Topics: Workshop Report (2011) / Chapter Skim
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Appendix A: Workshop Agenda
Pages 61-64

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From page 61...
... 10:20 Break FDA Postmarket Surveillance 10:30 Monitoring Device Safety: CDRH's Current System and Vision for the Future Susan Gardner, Director of the Center for Devices and Radiological Health's (CDRH's) Office of Surveillance and Biometrics 61
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From page 62...
... Maisel, Director, Medical Device Safety Institute 11:50 FDA Recall Data Study Ralph Hall, Distinguished Visiting Professor of Law, University of Minnesota Law School 12:30 PM Lunch Non-FDA Sources of Adverse Event Data 1:30 The National Cardiovascular Data Registries: Opportunities and Challenges in Postmarket Surveillance Frederick A Masoudi, MD, MSPH, Associate Professor of Medicine, Denver Health Medical Center & University of Colorado; Senior Medical Officer, National Cardiovascular Data Registries 2:00 The VA‑CART Program: Integration of Real‑Time Data Collection into the Process of Clinical Care Paul D
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From page 63...
... · arry Kessler, Professor and Chair, Department of L Health Services, School of Public Health, University of Washington 5:30 Adjourn
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Key Terms

  • medical device
  • ralph hall
  • fda recall
  • recall data
  • national cardiovascular

  • susan gardner
  • senior medical
  • distinguished visiting
  • colorado health
  • fred cobb

  • device safety
  • visiting professor
  • safety institute
  • health medical
  • cardiovascular data

  • project director
  • distinguished professor
  • delta surveillance
  • denver health
  • eastern colorado

  • medical officer
  • chief technology
  • data study
  • technology officer
  • automated postmarket

  • postmarket safety
  • monitoring device
  • cardiac electrophysiology
  • surveillance project
  • medical center


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