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Question Number 132
The two-step process of obtaining an FDA marketing approval for a HUD includes:A. Obtaining a HUD designation then submitting a Humanitarian Device Exemption (HDE) to the FDA.B. Submitting a pre-market approval (PMA) to FDA then obtaining a HUD designation.C. Obtaining a HUD designation then submitting a pre-market approval (PMA) to the FDA.D. Obtaining a HUD designation then submitting HUD use to an IRB.
A. Obtaining a HUD designation then submitting a Humanitarian Device Exemption (HDE) to the FDA.
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A. Obtaining a HUD designation then submitting a Humanitarian Device Exemption (HDE) to the FDA.
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