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FDA proposes Blade Implant Reclassification

The FDA (US Food and Drug Agency) is proposing to reclassifying blade implants in a possible come-back for this type of implant. In a FDA press release they are proposing to change the classification from Class III devices to Class II devices because the benefits of blade-form implants “outweigh the risks enough to justify reclassifying the implants from class III, requiring premarket approval, to class II, requiring premarket notification with special controls,”. Class II medical devices are of “medium risk,”