Zdrowie i gospodarka · 01/10/1999

FDA Proposes Classification of Subcutaneous and Implantable IV Devices

The FDA is proposing to classify subcutaneous, implanted, intravascular infusion ports and catheters, as well as percutaneous, implanted, long-term catheters, into Class II, requiring special controls, to ensure their safety and effectiveness. The agency will consider public comments before finalizing the classification.