Medical Devices; Immunology and Microbiology Devices; Classification of Clostridium Difficile Toxin Gene Amplification Assay
fda-device · Food and Drug Administration · Rule · Published 2015-08-27 · Effective 2015-09-28 · 80 FR 51938
Document
Document number
2015-21237
Federal Register citation
80 FR 51938
CFR reference
21 CFR 866
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2015-08-27
Effective date
2015-09-28
HHS docket
Docket No. FDA-2015-N-2963
Abstract
The Food and Drug Administration (FDA) is classifying Clostridium difficile (C. difficile) toxin gene amplification assay into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.