# Medical Devices; Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices
> **Food and Drug Administration** · Final rule. · Published 2004-06-23 · Effective 2004-06-23 · 69 FR 34917
## Document
- **Document number:** 04-14126
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 69 FR 34917
- **CFR reference:** 21 CFR 868
- **Publication date:** 2004-06-23
- **Effective date:** 2004-06-23
- **HHS docket:** Docket No. 2003N-0468
## Abstract

The Food and Drug Administration (FDA) is requiring the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following three class III preamendments devices: Indwelling blood oxyhemoglobin concentration analyzer, cardiopulmonary bypass pulsatile flow generator, and the ocular plethysmograph. The agency also is summarizing its proposed 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. This action implements certain statutory requirements.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2004/06/23/04-14126/medical-devices-effective-date-of-requirement-for-premarket-approval-for-three-class-iii)
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