Medical Devices; Reclassification and Codification of Home Uterine Activity Monitor
fda-device · Food and Drug Administration · Rule · Published 2001-03-09 · Effective 2001-04-09 · 66 FR 14074
Document
Document number
01-5813
Federal Register citation
66 FR 14074
CFR reference
21 CFR 884
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2001-03-09
Effective date
2001-04-09
HHS docket
Docket No. 97P-0350
Abstract
The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to GE Marquette Medical Systems, Inc., reclassifying from class III to class II (special controls) the Corometrics Model 770 Home Uterine Activity Monitoring System for use in women with a previous preterm delivery to aid in the detection of preterm labor. Accordingly, the order is being codified in the Code of Federal Regulations. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device.