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FDA Tutorial Workshop on Cardiovascular Investigational Device Exemptions for NIH investigators
Thursday, June 24, 2010,
9:00:00 AM Time displayed is Eastern Time, Washington DC Local
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The IDE process (content and organization) emphasis on preclinical engineering and animal test requirements for feasibility studies. Include answer to appropriate vs. inappropriate example of the HDE pathway vs. the IDE pathway. Explain in general terms how IDEs are used to support new uses/indications for existing devices or modifications to existing devices.