Zdrowie i gospodarka · 01/10/1999

General Hospital and Personal Use Devices; Classification of the Subcutaneous, Implanted, Intravascular Infusion Port and Catheter and the Percutaneous, Implanted, Long-term Intravascular Catheter

The Food and Drug Administration (FDA) is proposing to classify the subcutaneous, implanted, intravascular (IV) infusion port and catheter, and the percutaneous, implanted, long-term catheter intended for repeated vascular access into class II (special controls). The agency is also publishing the recommendations of FDA's General Hospital and Personal Use Devices Panel (the panel) regarding the classification of these devices. After considering public comments on the proposed classification, FDA will publish a final regulation classifying these devices. This action is being taken to establish sufficient regulatory controls that will provide reasonable assurance of the safety and effectiveness of these devices.