Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the current delays facing UK Coronavirus Test Device Approval (CTDA) assessments; and what plans his Department has to expedite the backlog before the February 2022 review deadline.
The backlog of tests in the Coronavirus Test Device Approval (CTDA) process was due to insufficient evidence submitted by applicants. We have since worked with applicants on the additional information required and permitted further time to submit this evidence. On 7 February 2022, we updated the online guidance for applicants to provide greater clarity on acceptance criteria for the range of viral loads within samples. The majority of applications are now meeting these standards and the rate of approvals is increasing.