Regulatory Strategies

Additional Information

MRN is experienced with all types of FDA submissions including 510(k), PMA, Humanitarian Use Devices and In Vitro Device Exemptions (IDEs).  We have designed regulatory strategies for tests that span the full range of diagnostic technologies including immunoassay, cell-based assays and molecular diagnostic technologies.  MRN has extensive experience with Laboratory Developed Testing strategies for high complexity CLIA-certified laboratories, and we have implemented compliant programs for Research Use Only and Investigational Use Only products, along with Analyte Specific Reagents.