federal_register: 00-14698

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
00-14698 General Hospital and Personal Use Devices; Classification of the Subcutaneous, Implanted, Intravascular Infusion Port and Catheter and the Percutaneous, Implanted, Long-term Intravascular Catheter Rule The Food and Drug Administration (FDA) is classifying the subcutaneous, implanted, intravascular (IV) infusion port and catheter, and the percutaneous, implanted, long-term IV catheter intended for repeated vascular access into class II (special controls). This action is being taken to establish sufficient regulatory controls that will provide reasonable assurance of the safety and effectiveness of these devices. 2000-06-13 2000 6 https://www.federalregister.gov/documents/2000/06/13/00-14698/general-hospital-and-personal-use-devices-classification-of-the-subcutaneous-implanted-intravascular https://www.govinfo.gov/content/pkg/FR-2000-06-13/pdf/00-14698.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is classifying the subcutaneous, implanted, intravascular (IV) infusion port and catheter, and the percutaneous, implanted, long-term IV catheter intended for repeated vascular access into class II (special...

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