Class II Special Controls Guideline: Nucleic Acid Amplification Assays for the Detection of Trichomonas vaginalis - Guideline for Industry and Food and Drug Administration Staff

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.
Source: Food and Drug Adminstration (FDA): CDRHNew - Category: Medical Equipment Source Type: news