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Seasonal Influenza IVD self-tests

Clinical performance requirements and risk mitigation strategies
18 March 2021
Download Seasonal Influenza IVD self-tests


The purpose of this document is to provide manufacturers and sponsors with guidance on the Therapeutic Goods Administration's (TGA) expectations concerning clinical performance requirements (i.e. clinical sensitivity and specificity) and risk mitigation for in vitro diagnostic medical devices (IVDs) intended to be used as self-tests for seasonal influenza.

  • Purpose
  • Background
  • Public health context
  • Clinical performance characteristics and risk mitigation strategies for IVD self-testing
  • Usability studies
  • Risks
  • Mitigation strategies

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