RE: LFT Product Wars & PathFlow® Release16 Jun 2021 06:22
@Kaeren
Just noticed your earlier post.
Nobody has responded I believe because the process is NOT totally clear, it looks like the DHSC COULD go against scientific or validation advise from PHE Porton Down, but I would think that highly unlikely, but both DHSC and PD are part of the “Oversight Group”. If DHSC approved something not validated and it caused damages a legal claim could be substantial…
From my research IF you are a business with an LFT device, in the first instance you apply to the DHSC. They will then undertake a desk-top review, including the submitted details of manufacturers’ claimed performance and instructions for use, to identify tests which may perform with sufficient sensitivity and very high specificity to enable them to be used to detect and direct responses to emerging outbreaks.
IF they do not like your application, or do not think your product is of sufficient standard the application goes no further and you are rejected.
IF they consider your product is of sufficient standard it is then passed to PHE Porton Down and they continue the validation process steps we previously outlined which starts with the manufacturer sending 500 of their test kits to go through the validation process.
At this point the product goes through all the evaluation process stages 1 to 3a.
Meanwhile, The Medicines and Healthcare products Regulatory Agency (MHRA) provides ongoing regulatory oversight, it is not able to directly grant a licence as far as I know without the product clearing the DHSC “Oversight Group” process.
So, regarding Innova, as it previously passed the evaluation process it COULD be possible that DHSC grant an extended license without further checks BUT would they really do that? Especially with the information they now have to hand. Also, the PD evaluation process is much more advanced now than it was back in sept 20 as such the Innova test should be properly re-evaluated. Anyhow we will know one way or another by Tuesday.
If anyone has more knowledge / experience on the above happy to stand corrected - Thanks
Pork’s