# Medical Devices; Reclassification and Codification of Home Uterine Activity Monitor
> **Food and Drug Administration** · Final rule. · Published 2001-03-09 · Effective 2001-04-09 · 66 FR 14074
## Document
- **Document number:** 01-5813
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 66 FR 14074
- **CFR reference:** 21 CFR 884
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2001/03/09/01-5813/medical-devices-reclassification-and-codification-of-home-uterine-activity-monitor)
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