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Premarket approval / Federal Food /  Drug /  and Cosmetic Act / Medical device / Ventricular assist device / Humanitarian Device Exemption / Clinical trial / Investigational Device Exemption / Center for Devices and Radiological Health / Medicine / Food and Drug Administration / Health
Premarket approval
Federal Food
Drug
and Cosmetic Act
Medical device
Ventricular assist device
Humanitarian Device Exemption
Clinical trial
Investigational Device Exemption
Center for Devices and Radiological Health
Medicine
Food and Drug Administration
Health

Regulatory Background on Reclassification

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