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IP and FDA Regulation of De Novo Medical Devices
Jacob S Sherkow
, Mateo Aboy
College of Law
Carl R. Woese Institute for Genomic Biology
Biomedical and Translational Sciences
European Union Center
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Keyphrases
Medical Devices
100%
FDA Regulation
100%
Technological Characteristics
50%
Special Control
50%
Device Use
25%
Technical Characteristics
25%
Device Type
25%
Application Process
25%
Evidence-based Research
25%
Application Requirements
25%
Classification Process
25%
Control Characteristics
25%
Premarket
25%
Device Classification
25%
Predicate Device
25%
Clearance Mechanism
25%
21st Century Cures Act
25%
Computer Science
Speed-up
100%
Application Requirement
100%
Application Process
100%
Classification Process
100%
Computer Hardware
100%
Material Science
Medical Device
100%
Device Type
25%