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Zdrowie i gospodarka · 08/10/2021

FDA Reclassifies Surgical Staplers for Internal Use from Class I to Class II

The US Food and Drug Administration (FDA) is reclassifying surgical staplers for internal use from general controls to special controls, requiring premarket review, due to new information and the need for additional safety and effectiveness controls.

Source: Federal Register — Food and Drug AdministrationOpen original release →