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FDA Presentation 07/17/07

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VistA Imaging The Regulatory Environment Daniel Carozza, MD RAC 17 July 2007
Overview – Today’s FDA Regulation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
General Concepts ,[object Object]
General Concepts ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
The FDA ,[object Object],[object Object],[object Object],[object Object]
History of Medical Device Regulation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Organization of the FDA ,[object Object],[object Object],[object Object]
Device Classification ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Definition – Medical Device ,[object Object],[object Object],[object Object]
Class I Devices ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Class I Devices ,[object Object],[object Object],[object Object],[object Object],[object Object]
Class I Devices ,[object Object],[object Object],[object Object]
Class II Device ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Class III Devices ,[object Object],[object Object]
Humanitarian Devices ,[object Object],[object Object]
FDA Clearance for Marketing ,[object Object],[object Object],[object Object]
Medical Device Reporting ,[object Object],[object Object],[object Object]
Tracking Requirements ,[object Object],[object Object]
Removals and Corrections ,[object Object],[object Object]
Postmarket Surveillance ,[object Object],[object Object]
FDA Recall Authority ,[object Object],[object Object],[object Object],[object Object],[object Object]
Quality System Requirement ,[object Object],[object Object],[object Object],[object Object],[object Object]
Regulatory Practices Applied to Imaging ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Usage Agreement ,[object Object],[object Object],[object Object],[object Object]
Implementation Process ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Local Configuration & Modifications ,[object Object],[object Object]
Local Modifications ,[object Object]
Prescription Use of Imaging ,[object Object]
Usage and Test Agreements ,[object Object]
Training & Education ,[object Object],[object Object],[object Object],[object Object]
Tracking and Reporting ,[object Object],[object Object],[object Object]
Tracking Requirement ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Potential Consequences of Misuse ,[object Object],[object Object],[object Object],[object Object]
Questions?
Commercial Components Used by VistA Imaging as of July 2007 ,[object Object],[object Object],[object Object],[object Object],[object Object]
Commercial Components Used by VistA Imaging ,[object Object],[object Object],[object Object],[object Object],[object Object]
Commercial Components Used by VistA Imaging ,[object Object],[object Object],[object Object],[object Object],[object Object]
Commercial Components Used by VistA Imaging ,[object Object],[object Object],[object Object],[object Object],[object Object]

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FDA Presentation 07/17/07

  • 1. VistA Imaging The Regulatory Environment Daniel Carozza, MD RAC 17 July 2007
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