Regulatory Strategies

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.  We are intimately familiar with FDA policy and Dr. Allard served as the Industry Representative on the Immunology Device Advisory Panel from 2005 – 2008.  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.

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