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NAMSA Guide: The Design of Clinical Trials for CLIA-Waived Point-of-Care Tests

IVD products play a critical role in the global healthcare system, impacting about 70 percent of all diagnostic decisions. Due to advances in technology, software and analytics, the number of IVD CLIA-waived tests have steadily increased in recent years, allowing for more testing to be performed outside clinical laboratory settings. From diabetes management to screening for infectious diseases, CLIA-waived tests have become an integral part of patient care at or near the patient and can be performed using hand-held devices at the bedside or at the Point-of-Care (POC).

To be awarded CLIA waiver status, manufacturers must demonstrate that a specific test system is easy to use, carries low risk associated with an incorrect result and is accurate in the hands of the intended user. Often, the path to achieving waived status is achieved in two parts: 1) PMA submission to the FDA; and 2) CLIA waiver by application (CW).

Access NAMSA’s White Paper, “The Design of Clinical Trials for CLIA-Waived Point-of-Care Tests,” to learn how setting intended goals for a CLIA waiver determination early in the product design phase allows manufacturers to implement the necessary control measures to mitigate risks and expedite the waiver determination process.

Discussed within are the following topics:

  • Clinical Applications
  • Role of CLIA
  • Regulatory Pathway for CLIA-Waived Tests
  • CLIA Waiver by Application
  • Gauging the Simplicity of the Test
  • Gauging the Test System for Insignificant Risk of Erroneous Results
  • Risk Analysis
  • Control Measures
  • Accuracy of the Test in the Hands of the Intended User
  • General Clinical Study Design Considerations
  • Key Factors for CLIA Waiver Study Design

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