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Home FDA’s Reclassifies Sharps Needle Destruction Device

FDA’s Reclassifies Sharps Needle Destruction Device

on: May 03, 2018In:
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Agency believes final order will decrease regulatory burden on manufacturers as they will no longer be required to submit a premarket approval application (PMA), but can instead submit a less-burdensome premarket notification (510(k)) before marketing this type of device

Source: HCP general
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