COVID-19 Support Services: In Vitro Diagnostic Testing

In vitro diagnostic (IVD) testing is a critical component in the fight against COVID-19, and test developers have rushed to meet the demand. However, as more people have been vaccinated, the focus for the IVD testing community has shifted from developing tests designed to detect the virus to those designed to test several different analytes, to characterize an individual’s immune response, and to increase the accessibility of testing. With growing pressure to develop new tests quickly under changing user requirements, the transition from Emergency Use Authorization (EUA) submissions to De Novo/510(k) submissions and the shifting needs in each new phase of the pandemic have made navigating the complex and dynamic public health and regulatory environment increasingly challenging.
Our team of IVD, medical device, and pharmaceutical industry professionals can provide support across the entire IVD product development lifecycle, from feasibility, test development, verification and validation, regulatory submission and approval, to post-market surveillance with knowledge and experience involving microfluidics, software, digital diagnostics, manufacturing, chemistry, biology, regulatory strategy, real world evidence-based studies, epidemiology and more. We can develop safety information for products and processes that complies with pertinent standards, regulations, and best practices. With extensive knowledge in assay and detection technologies, Software as a Medical Device (SaMD) regulations, artificial intelligence, quality system establishment, FDA assessments compliance, and Clinical Laboratory Improvement Amendments (CLIA) requirements, we can assist in reviewing submission packages, auditing labs, or performing due diligence and validation/technical design of the assay, instrument, or collection kit. Our expertise also includes reviewing diagnostic data to assess the completeness of a package for submission according to any of the Emergency Use Authorization (EUA) pathways or 510(k)/de novo submissions.

Leveraging Exponent’s deep multi-disciplinary technical expertise and experience, we provide a wide range of services including:

  • Supporting assay and instrument development for decentralized home testing and long-term disease management
  • Designing and executing usability studies to identify potential use errors and performing comprehension studies
  • Global regulatory support for In Vitro Diagnostic Regulation (IVDR), World Health Organization (WHO), and FDA submissions including EUA, 510(k), De Novo, and PMA packages
  • Digital health development including SaMD, artificial intelligence, and digital diagnostics
  • Evaluating batteries in point-of-care/at home tests and in portable IVD wearables
  • Performing risk management activities, failure modes and effects analysis, failure testing, health hazard evaluations, root-cause analyses, and risk mitigation
  • Developing and implementing corrective and preventive action plans
  • Assessing technical due diligence based on mergers and acquisitions or investment opportunities.

For more information on our services, please contact 888.656.EXPO (within the U.S.), 650.326.9400 (outside the U.S.), or Additional information is also available here.