Question to the Department of Health and Social Care:
To ask Her Majesty's Government what plans they have to re-evaluate the Coronavirus Test Device Approvals process in relation to future pandemics; and whether the approval process for new diagnostic tests for other infectious diseases will remain under the authority of the UK Health Security Agency.
The Coronavirus Test Device Approvals (CTDA) process is designed to evaluate mature COVID-19 testing technologies and the scope of the policy is kept under review. The UK Health Security Agency (UKHSA) has consulted with industry and the public on the expansion of the CTDA process and is currently analysing the responses received. The UKHSA is considering its regulatory role in relation to testing for other infectious diseases and we have committed to reviewing the CTDA process by the end of 2022.