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SPECIAL CONTROLS DOCUMENT

Class II Special Controls Guideline: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens Guideline for Industry and Food and Drug Administration November 2015

Final
Docket Number:
FDA-2015-N-3392
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco

This special controls guideline was developed to support the classification of a gastrointestinal microorganism multiplex nucleic acid-based assay into class II (special controls).

This guideline identifies measures that FDA believes will mitigate the risks to health associated with these devices and provide a reasonable assurance of safety and effectiveness. Firms submitting a 510(k) for a gastrointestinal microorganism multiplex nucleic acid-based assay will need either to (1) comply with the particular mitigation measures set forth in the special controls guideline or (2) use alternative mitigation measures, but demonstrate to the Agency's satisfaction that those alternative measures identified by the firm will provide at least an equivalent assurance of safety and effectiveness.


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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
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-3392.