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FDA Tutorial Workshop on Cardiovascular Investigational Device Exemptions for NIH investigators

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Air date: Thursday, June 24, 2010, 9:00:00 AM
Time displayed is Eastern Time, Washington DC Local
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Category: Conferences
Runtime: 05:06:26
Description: 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.
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Author: Dr Robert Lederman
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CIT Live ID: 9365
Permanent link: http://videocast.nih.gov/launch.asp?15997