- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice 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.
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:
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.