Investigational Device Exemptions

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Role of Investigational Device Exemption
Date: 7/27/2011
Length: 2 minutes
Speaker(s): Howard Holstein
Sources: Stanford Biodesign
Description: Paul Yock interviews Howard Holstein, regulatory attorney, on investigational Device Exemptions: Question 3: What is the role of an IDE and initiating that process?

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Need for Meeting with FDA Prior to IDE
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Summary: Paul Yock interviews Howard Holstein, regulatory attorney, on investigational Device Exemptions: Question 5: What advice do you have for an innovator prior to meeting with the FDA in the IDE process? Watch More
Need for Clinical Trials
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Summary: Paul Yock interviews Howard Holstein, regulatory attorney, on investigational Device Exemptions: Question 1: Are clinical trials always needed before getting clearance or approval from the FDA?
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Need for Meeting with FDA Prior to IDE
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Summary: Paul Yock interviews Howard Holstein, regulatory attorney, on investigational Device Exemptions: Question 4: Should a company always meet with the FDA before launching an IDE process?
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Role of Investigational Device Exemption
Howard Holstein
7/27/2011
Summary: Paul Yock interviews Howard Holstein, regulatory attorney, on investigational Device Exemptions: Question 3: What is the role of an IDE and initiating that process?
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US vs. Outside US Trials
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Summary: Paul Yock interviews Howard Holstein, regulatory attorney, on investigational Device Exemptions: Question 2: Must trials occur in the U.S.?
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