# Medical Devices; General and Plastic Surgery Devices; Classification of Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology
> **Food and Drug Administration** · Final rule. · Published 2007-08-03 · Effective 2007-09-04 · 72 FR 43144
## Document
- **Document number:** E7-15064
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 72 FR 43144
- **CFR reference:** 21 CFR 878
- **Publication date:** 2007-08-03
- **Effective date:** 2007-09-04
- **HHS docket:** Docket No. 2007N-0267
## Abstract

The Food and Drug Administration (FDA) is classifying the absorbable poly(hydroxybutyrate) surgical suture produced by recombinant deoxyribonucleic acid (DNA) technology into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology." 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. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2007/08/03/E7-15064/medical-devices-general-and-plastic-surgery-devices-classification-of-absorbable-polyhydroxybutyrate)
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