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Technology / Premarket approval / Federal Food /  Drug /  and Cosmetic Act / Medical device / Humanitarian Device Exemption / Ventricular assist device / Clinical trial / Device file / Title 21 of the Code of Federal Regulations / Medicine / Food and Drug Administration / Health
Technology
Premarket approval
Federal Food
Drug
and Cosmetic Act
Medical device
Humanitarian Device Exemption
Ventricular assist device
Clinical trial
Device file
Title 21 of the Code of Federal Regulations
Medicine
Food and Drug Administration
Health

Regulatory Background on Reclassification

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