Zdrowie i gospodarka · 03/07/2007

FDA Proposes Reclassification of Tissue Adhesive for Topical Approximation of Skin Device

The US Food and Drug Administration (FDA) is proposing to reclassify the Tissue Adhesive for Topical Approximation of Skin Device from a Class III (premarket approval) to a Class II (special controls) classification, effective 60 days after the final rule is published in the Federal Register. This change would allow the device to be sold with special controls, rather than requiring a premarket approval application (PMA) for non-topical uses.