Coronavirus Test Device Approvals (CTDA): statutory review of process
A policy review of the CTDA process, established in July 2021, which governs the validation of antigen and molecular coronavirus (COVID-19) detection tests.
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The Coronavirus Test Device Approvals (CTDA) requires antigen and molecular COVID-19 tests to undergo mandatory desktop review by The Medicines and Healthcare products Regulatory Agency (MHRA) to assess their performance before being put into service or placed on the market.
This review sets out the context in which the legislation was introduced, including the course of the pandemic at the time and the availability of testing.
It assesses the operational performances of the CTDA and uses that assessment to inform whether and to what extent the CTDA has met its original objectives. It also considers the alternative models for diagnostic device validation.