Issue Date: 08/04/2015
Issued By: Office of Medical Products and Tobacco, Center for Devices and Radiological Health, Office of In Vitro Diagnostics and Radiological Health
This special controls guideline was developed to support the classification of a Trichomonas vaginalis nucleic acid 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) premarket notification for a Trichomonas vaginalis nucleic acid 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 equivalent assurance of safety and effectiveness.