Is VeriPsych FDA approved?
• Federal law allows laboratories to offer Laboratory-Developed Tests without undergoing approval for marketing from the U.S. Food and Drug Administration (FDA). Laboratory-Developed Tests do not require approval for marketing from FDA because they are the activity of a single laboratory, not a traditional device manufacturer, and are not commercially marketed to other labs. These types of tests do go through rigorous validation procedures and must meet several criteria before results can be used for decisions regarding patient care. VeriPsych is a Laboratory-Developed Test. VeriPsych was developed and its performance characteristics were determined by Rules-Based Medicine (RBM). The RBM laboratory is regulated under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high-complexity testing.
