Medical Devices; Immunology and Microbiology Devices; Classification of the Endotoxin Assay; Technical Amendment

---
identifier: "/us/fr/05-17645"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Medical Devices; Immunology and Microbiology Devices; Classification of the Endotoxin Assay; Technical Amendment"
title_number: 0
title_name: "Federal Register"
section_number: "05-17645"
section_name: "Medical Devices; Immunology and Microbiology Devices; Classification of the Endotoxin Assay; Technical Amendment"
positive_law: false
currency: "2005-09-07"
last_updated: "2005-09-07"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "05-17645"
document_type: "rule"
publication_date: "2005-09-07"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
cfr_references:
  - "21 CFR Part 866"
fr_citation: "70 FR 53069"
fr_volume: 70
docket_ids:
  - "Docket No. 2003D-0221"
effective_date: "2005-09-07"
fr_action: "Final rule; technical amendment."
---


#  [Redesignated as § 866.3210 ]

**AGENCY:**

Food and Drug Administration, HHS.

**ACTION:**

Final rule; technical amendment.

**SUMMARY:**

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 § 866.3610 to § 866.3210.

**DATES:**

This rule is effective September 7, 2005.

**FOR FURTHER INFORMATION CONTACT:**

Freddie M. Poole, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240-276-0496 ext. 1111.

**SUPPLEMENTARY INFORMATION:**

FDA has found that the endotoxin assay regulation does not reflect the correct section number listed in the CFR. Accordingly, FDA is amending the regulation in § 866.3610 (21 CFR 866.3610) to correct the error by redesignating the section number from § 866.3610 to 866.3210.

**List of Subjects in 21 CFR Part 866**

Biologics, Laboratories, Medical devices.

**21 CFR Part 866**

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows:

**21 CFR Part 866**

**PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES**

1. The authority citation for 21 CFR part 866 continues to read as follows:

**Authority:**

21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

**21 CFR Part 866**

§ 866.3610

2. Section 866.3610 is redesignated as § 866.3210.

Dated: August 26, 2005.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.