# Medical Devices; Obstetrical and Gynecological Devices; Classification of Computerized Labor Monitoring System
> **Food and Drug Administration** · Final rule. · Published 2007-04-24 · Effective 2007-05-24 · 72 FR 20225
## Document
- **Document number:** E7-7702
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 72 FR 20225
- **CFR reference:** 21 CFR 884
- **Publication date:** 2007-04-24
- **Effective date:** 2007-05-24
- **HHS docket:** Docket No. 2007N-0120
## Abstract

The Food and Drug Administration (FDA) is classifying the computerized labor monitoring systems into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled, "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems," which will serve as the special controls for these devices. The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2007/04/24/E7-7702/medical-devices-obstetrical-and-gynecological-devices-classification-of-computerized-labor)
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