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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This guidance is being distributed for comment purposes only.

Class II Special Controls Guideline: In Vitro Diagnostic Devices for Bacillus spp. Detection

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