NHS Test and Trace response to MHRA on incident reference: 2021/006/011/601/004
Published 21 March 2024
漏 Crown copyright 2024
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The Department of Health and Social Care (DHSC) COVID-19 self test lateral flow device (LFD) was lawfully introduced to the UK market when聽NHS Test and Trace聽(DHSC), as legal manufacturer of the product, obtained an exceptional use authorisation in December 2020 from the Medicines and Healthcare products Regulatory Agency (MHRA). This is the correct regulatory process in the UK for products that have not yet been assessed by a UK approved body (see聽Medical devices: UK approved bodies).
罢丑别听DHSC聽COVID-19 self-test kits were provided under a supply contract by Innova and manufactured by Xiamen Biotime. In June 2021, the US Food and Drug Administration (FDA) released a聽. This triggered the聽MHRA聽to declare an incident to which NHS Test and Trace聽(DHSC) was required to respond as legal manufacturer. A Corrective and Preventative Action report was submitted to the MHRA providing evidence of why, in the UK setting, the FDA concerns did not apply.