# Medical Devices; Effective Date of Requirement for Premarket Approval for Three Preamendment Class III Devices
> **Food and Drug Administration** · Final rule. · Published 2000-04-13 · Effective 2000-04-13 · 65 FR 19833
## Document
- **Document number:** 00-9135
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 65 FR 19833
- **CFR reference:** 21 CFR 868
- **Publication date:** 2000-04-13
- **Effective date:** 2000-04-13
- **HHS docket:** Docket No. 98N-0564
## Abstract

The Food and Drug Administration (FDA) is issuing a final rule to retain three class III preamendment devices in class III and to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following devices: The lung water monitor, the powered vaginal muscle stimulator, and the stair-climbing wheelchair. The agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices 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/2000/04/13/00-9135/medical-devices-effective-date-of-requirement-for-premarket-approval-for-three-preamendment-class)
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