COVID-19 self-test LFD exceptional use application to MHRA
Documents submitted to MHRA requesting exceptional use authorisation for a self-use LFD and the response to MHRA incident reference 2021/006/011/601/004.
Documents
Details
The Department of Health and Social Care (DHSC) COVID-19 self-test lateral flow device (LFD) was lawfully introduced to the UK market when the 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.
The Incident and Corrective and Preventative Action Report details the formal review that NHS Test and Trace undertook at the request of the MHRA in June 2021 when the US Food and Drug Administration (FDA) released a safety notice in the US for the Innova LFD Antigen Test. The review summarises the reasons why DHSC continued to use the product in the UK.