Medical Devices; Immunology and Microbiology Devices; Classification of the Endotoxin Assay; Technical Amendment
fda-device · Food and Drug Administration · Rule · Published 2005-09-07 · Effective 2005-09-07 · 70 FR 53069
Document
Document number
05-17645
Federal Register citation
70 FR 53069
CFR reference
21 CFR 866
Type
Rule
Action
Final rule; technical amendment.
Category
fda-device
Sub-agency
Food and Drug Administration
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.