Cardiovascular, Orthopedic, and Physical Medicine Diagnostic Devices; Reclassification of Cardiopulmonary Bypass Accessory Equipment, Goniometer Device, and Electrode Cable Devices
fda-device · Food and Drug Administration · Rule · Published 2000-04-11 · Effective 2000-05-11 · 65 FR 19317
Document
Document number
00-8850
Federal Register citation
65 FR 19317
CFR reference
21 CFR 870
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2000-04-11
Effective date
2000-05-11
HHS docket
Docket No. 99N-2210
Abstract
The Food and Drug Administration (FDA) is reclassifying from class I into class II the cardiopulmonary bypass accessory equipment device that involves an electrical connection to the patient, the goniometer device, and the electrode cable. FDA is also exempting these devices from the premarket notification requirements. FDA is reclassifying these devices on its own initiative based on new information. FDA is taking this action to establish sufficient regulatory controls that will provide reasonable assurance of the safety and effectiveness of these devices.