# Neurological Devices; Classification of Human Dura Mater
> **Food and Drug Administration** · Final rule. · Published 2003-12-18 · Effective 2004-01-20 · 68 FR 70435
## Document
- **Document number:** 03-31174
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 68 FR 70435
- **CFR reference:** 21 CFR 882
- **Publication date:** 2003-12-18
- **Effective date:** 2004-01-20
- **HHS docket:** Docket No. 2002N-0370
## Abstract

The Food and Drug Administration (FDA) is classifying human dura mater intended to repair defects in human dura mater into class II (special controls). This action is being taken to establish sufficient regulatory control to provide reasonable assurance of the safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Class II Special Controls Guidance Document: Human Dura Mater" that will serve as the special control for this device.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2003/12/18/03-31174/neurological-devices-classification-of-human-dura-mater)
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