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SPECIAL CONTROLS DOCUMENT

Class II Special Controls Guideline: In Vitro Diagnostic Devices for Bacillus spp. Detection Guideline for Industry and Food and Drug Administration Staff April 2019

Final

This guidance is being distributed for comment purposes only.

Docket Number:
FDA-2011-N-0103
Issued by:
Guidance Issuing Office
Center 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.


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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:

Dockets Management
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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2011-N-0103.