Question to the Department of Health and Social Care:

To ask Her Majesty's Government what steps they are taking to address the reported bottleneck in the Coronavirus Test Device Approval process.

Current delays in the Coronavirus Test Device Approval (CTDA) process have been due to further information being sought from applicants during the validation process. However, to ensure applications meet the required standards, expert support has been provided by officials, with 60% of approvals being processed in the last three months.

The number of scientific advisors has also been increased to meet demand. Online guidance for applicants has also been updated to provide greater clarity for acceptance criteria for the range of viral loads within positive samples. Officials continue to work with applicants to provide support during the process and minimise any potential delays.