United States:
FDA Classifies Clostridium Difficile Toxin Gene Amplification Assay Into Class II
14 September 2015
Jones Day
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In the August 27, 2015, Federal
Register, FDA announced it has classified the
Clostridium difficile (C. difficile) toxin gene
amplification assay into Class II (special controls) medical
device. Labeling and performance studies are required to mitigate
identified risks.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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