TGA Updates Guidance on COVID-19 Rapid Antigen Test Performance and Risk Mitigation
The TGA has updated its guidance on performance requirements and risk mitigation for COVID-19 rapid antigen tests, covering analytical and clinical evidence, self-test usability, IFU requirements, software, COR approvals and post-market monitoring.
TGA Updates Guidance on IVD Self-Tests for Chlamydia, Gonorrhoea and Syphilis
The TGA has updated its guidance on clinical performance and risk mitigation requirements for IVD self-tests for chlamydia, gonorrhoea and syphilis, including study design, usability, IFU and post-market monitoring expectations.
European Commission Launches Survey on Electronic Instructions for Use for Medical Devices
The European Commission is considering allowing electronic instructions for use for all professional-use medical devices and has launched a survey for healthcare professionals and healthcare institutions in the EU.