# Medical Devices; Effective Date of Requirement for Premarket Approval for a Class III Preamendments Obstetrical and Gynecological Device
> **Food and Drug Administration** · Final rule. · Published 2000-07-05 · Effective 2000-07-05 · 65 FR 41330
## Document
- **Document number:** 00-16808
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 65 FR 41330
- **CFR reference:** 21 CFR 884
- **Publication date:** 2000-07-05
- **Effective date:** 2000-07-05
- **HHS docket:** Docket No. 95N-0084
## Abstract

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of product development protocol (PDP) for a Group 1 preamendments class III device, the obstetric data analyzer intended to analyze data from fetal and maternal monitors during labor and to warn of possible fetal distress. The agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to meet the statute's approval requirements and the benefits to the public from the use of the devices.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2000/07/05/00-16808/medical-devices-effective-date-of-requirement-for-premarket-approval-for-a-class-iii-preamendments)
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