[Federal Register Volume 70, Number 172 (Wednesday, September 7, 2005)]
[Rules and Regulations]
[Page 53069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-17645]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. 2003D-0221]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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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 
Sec.  866.3610 to Sec.  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 Sec.  866.3610 (21 
CFR 866.3610) to correct the error by redesignating the section number 
from Sec.  866.3610 to 866.3210.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

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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:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

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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.


Sec.  866.3610  [Redesignated as Sec.  866.3210 ]

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2. Section 866.3610 is redesignated as Sec.  866.3210.

    Dated: August 26, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-17645 Filed 9-6-05; 8:45 am]
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