General Hospital and Personal Use Devices; Classification of the Subcutaneous, Implanted, Intravascular Infusion Port and Catheter and the Percutaneous, Implanted, Long-term Intravascular Catheter
hospital-facility · Food and Drug Administration · Rule · Published 2000-06-13 · Effective 2000-07-13 · 65 FR 37041
Document
Document number
00-14698
Federal Register citation
65 FR 37041
CFR reference
21 CFR 880
Type
Rule
Action
Final rule.
Category
hospital-facility
Sub-agency
Food and Drug Administration
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.