# Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices
> **Food and Drug Administration** · Final rule. · Published 2011-08-16 · Effective 2011-08-23 · 76 FR 50663
## Document
- **Document number:** 2011-20664
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 76 FR 50663
- **CFR reference:** 21 CFR 870
- **Publication date:** 2011-08-16
- **Effective date:** 2011-08-23
- **HHS docket:** Docket No. FDA-2010-N-0412
## 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 a product development protocol (PDP) for the following three class III preamendments devices: Ventricular bypass (assist) device; pacemaker repair or replacement material; and female condom. 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. This action implements certain statutory requirements.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2011/08/16/2011-20664/effective-date-of-requirement-for-premarket-approval-for-three-class-iii-preamendments-devices)
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