You are here
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.
- Public health context
- Clinical performance characteristics and risk mitigation strategies for IVD self-testing
- Usability studies
- Mitigation strategies
We aim to provide documents in an accessible format. If you are having problems using a document with your accessibility tools, please contact us for help.