NHS Test and Trace response to MHRA on incident reference: 2021/006/011/601/004
Published 21 March 2024
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This publication is available at https://www.gov.uk/government/publications/covid-19-self-test-lfd-exceptional-use-application-to-mhra/nhs-test-and-trace-response-to-mhra-on-incident-reference-2021006011601004
The Department of Health and Social Care (DHSC) COVID-19 self test lateral flow device (LFD) was lawfully introduced to the UK market when NHS Test and Trace (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 Medical devices: UK approved bodies).
The DHSC 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 safety notice for the Innova LFD antigen test. This triggered the MHRA to declare an incident to which NHS Test and Trace (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.
Download the incident and Corrective and Preventative Action (CAPA) report to MHRA