# General Hospital and Personal Use Devices; Classification of the Subcutaneous, Implanted, Intravascular Infusion Port and Catheter and the Percutaneous, Implanted, Long-term Intravascular Catheter
> **Food and Drug Administration** · Final rule. · Published 2000-06-13 · Effective 2000-07-13 · 65 FR 37041
## Document
- **Document number:** 00-14698
- **Category:** hospital-facility
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 65 FR 37041
- **CFR reference:** 21 CFR 880
- **Publication date:** 2000-06-13
- **Effective date:** 2000-07-13
- **HHS docket:** Docket No. 99N-2099
## Abstract

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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2000/06/13/00-14698/general-hospital-and-personal-use-devices-classification-of-the-subcutaneous-implanted-intravascular)
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