This article was originally published in The Gray Sheet
Executive SummaryFinal rule issued June 13 classifies subcutaneous, implanted, I.V. infusion ports and catheters (CFR 880.5965) and percutaneous, implanted, long term intravascular catheters (CFR 880.5970), as Class II with respective device-specific guidance on premarket submissions as special controls. Manufacturers of the previously unclassified devices include SIMS Deltec, Horizon Medical/Strato/Infusaid, and Bard Access Systems
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