Question to the Department of Health and Social Care:

To ask Her Majesty's Government, following the introduction of updated COVID-19 test validation approval processes (CTDA), what guidance is available to testing manufacturers regarding submitting applications (1) for new tests and (2) for an updated approved product; and what is the expected timescale from application to decision for such applications.

The online only guidance COVID-19 test approval: how to apply advises testing manufacturers on the validation process for new devices. The guidance sets out the process from submitting an application; the desktop review; how payment can be made; the outcome reporting on tests which have passed; how to make a complaint; and where an application is unsuccessful, how the manufacturer can request a review of the decision.

For updates to products while an application is being considered, applicants must inform the COVID-19 Test Device Validation Approval processes (CTDA) administration team and provide the updated Instructions for Use. For updates to approved products, manufacturers are encouraged to contact the CTDA administration team. Guidance for such updates is currently being developed.

The CTDA team aim to have the results of the application review within 20 working days of submission, subject to the application being complete. This process may take longer where there is a high volume of applications and if there are additional queries on the data submitted.