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Classroom Contents
Development and Regulation of Medical Devices - Lecture 13
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- 1 Intro
- 2 Safe Therapeutic Products
- 3 Outline
- 4 Science Cycle
- 5 Regulatory Cycle
- 6 Device...
- 7 Combination Product Jurisdiction
- 8 Safe and Effective
- 9 Safety
- 10 Effectiveness
- 11 Device Classification
- 12 Class II: General and Special Controls
- 13 Class III: General Controls and Premarket Approval
- 14 Approval for marketing: PMA Application
- 15 Humanitarian Device Exemption
- 16 Practice of Medicine
- 17 Unapproved/Uncleared Devices
- 18 Testing Strategy (simplified)
- 19 IDE Decision Tree
- 20 IDE: Purpose
- 21 IDE: Investigation
- 22 Exemptions
- 23 Protocol Review/Approval Process
- 24 Required Elements of an IDE (partial list)
- 25 Recurring Myths
