# Medical Devices; Immunology and Microbiology Devices; Classification of the Endotoxin Assay; Technical Amendment
> **Food and Drug Administration** · Final rule; technical amendment. · Published 2005-09-07 · Effective 2005-09-07 · 70 FR 53069
## Document
- **Document number:** 05-17645
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 70 FR 53069
- **CFR reference:** 21 CFR 866
- **Publication date:** 2005-09-07
- **Effective date:** 2005-09-07
- **HHS docket:** Docket No. 2003D-0221
## Abstract

The Food and Drug Administration (FDA) published a final rule in the Federal Register of October 31, 2003 (68 FR 62007). The final rule classified the endotoxin assay into class II (special controls). The agency classified the device into class II (special controls) in order to provide reasonable assurance of safety and effectiveness of the device. FDA is amending the agency's regulations to redesignate the section number listed in the Code of Federal Regulations (CFR) from Sec. 866.3610 to Sec. 866.3210.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2005/09/07/05-17645/medical-devices-immunology-and-microbiology-devices-classification-of-the-endotoxin-assay-technical)
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