Explore the development and regulation of medical devices in this 43-minute lecture from the NIH Clinical and Translational Research Summer Course. Gain insights into the science and regulatory cycles, device classification, and approval processes for marketing medical devices. Learn about safety and effectiveness considerations, humanitarian device exemptions, and the practice of medicine. Understand the testing strategy, Investigational Device Exemption (IDE) decision tree, and the purpose of IDEs. Discover the protocol review and approval process, required elements of an IDE, and debunk recurring myths in the field. This presentation by Bill Pritchard from the NIH Clinical Center offers valuable knowledge for those interested in the medical device industry and regulatory landscape.
Overview
Syllabus
Intro
Safe Therapeutic Products
Outline
Science Cycle
Regulatory Cycle
Device...
Combination Product Jurisdiction
Safe and Effective
Safety
Effectiveness
Device Classification
Class II: General and Special Controls
Class III: General Controls and Premarket Approval
Approval for marketing: PMA Application
Humanitarian Device Exemption
Practice of Medicine
Unapproved/Uncleared Devices
Testing Strategy (simplified)
IDE Decision Tree
IDE: Purpose
IDE: Investigation
Exemptions
Protocol Review/Approval Process
Required Elements of an IDE (partial list)
Recurring Myths
Taught by
NIH Clinical Center
