Class II Special Controls Guideline: In Vitro Diagnostic Devices for Bacillus spp. Detection
- Docket Number:
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Guidance Issuing OfficeCenter for Devices and Radiological Health
This special controls guideline was developed to establish special controls for in vitro diagnostic devices for Bacillus species (spp.) detection.
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-2011-N-0103.