MHRA extends EUA for NHS Test and Trace LFDs following satisfactory review amid coronavirus (COVID-19)

MHRA extends EUA for NHS Test and Trace LFDs following satisfactory review amid coronavirus (COVID-19)

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that it has extended the Exceptional Use Authorisation (EUA) of NHS Test and Trace lateral flow devices (LFDs) following a satisfactory review amid the coronavirus (COVID-19) pandemic. The review was taken as a result of a recent action in the US, where the US Food and Drug Administration issued a warning in relation to LFDs manufactured by Innova Medical Group Inc in the US. Innova is the supplier of NHS Test and Trace LFDs.

Speaking on Innova’s LFDs, MHRA Director of Devices, Graeme Tunbridge, stated the following: ‘Our priority is to ensure patients and the public have access to safe and effective medical devices and tests. Following our normal process to investigate any product concern, the MHRA immediately began reviewing all available information. A full risk assessment was undertaken by DHSC as legal manufacturer of the LFDs in the UK and the MHRA has undertaken a thorough review to ensure that we were satisfied with the assessment and any action proposed.

We have now concluded our review of the risk assessment and are satisfied that no further action is necessary or advisable at this time. This has allowed us to extend the EUA to allow ongoing supply of these LFDs over the coming months. People can be assured of the MHRA’s work to continuously monitor the tests in use, as is our standard process.’

Innova’s LFDs are authorised to be used to detect coronavirus in asymptomatic people, and are to be used for one-off testing prior to an activity to reduce risks, as well as for outbreak testing.

EUAs are issued by the MHRA during exceptional circumstances in order to allow medical devices to be used outside of the standard approval process. The EUA process has been used during the ongoing coronavirus pandemic to ensure that the UK health system receives critical medical products.  Once an EUA is issued by the MHRA, the regulator closely monitors those products approved under the process.

Source: Following a satisfactory review, MHRA extends authorisation of NHS Test and Trace lateral flow devices

Related Articles:
Latest Articles: