Class II Special Controls Guideline Document: Toxin Gene Amplification Assays for the Detection of Clostridium difficile
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological Health
This special controls guideline was developed to support the classification of a Clostridium difficile toxin gene amplification assay into class II (special controls).
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2015-N-2963.