RE: The Times today10 Nov 2021 11:42
Hi Mia,
I am not an expert (don't tell me, you already guessed haha!). Even if any of us were experts, it wouldn't have any bearing on the regulatory decision so all we can do is try our best to figure things out. I do have my own very amateurish opinion based on dealing with Gas Safe register and The Council of Registered Gas Installers. NSI; National Security device Installation inspectorate. These are regulatory bodies but certainly not on the same level as FDA.
FDA would examine/scrutinize:
1. A Parsortix unit
2. A number of cassettes etc (unused).
3. Not sure how assays (in general terms) fit in but that is a part of the complete process...
4. May have been given a demonstration of how the system works (by Zoom or other means)
5. Such a demonstration would not include an actual blood sample IMO as it may influence a decision either way. Maybe a saline solution to prove proof of concept rather than scientific relevance.
6. A detailed & step by step guide of how to use.
They would certainly look at the manufacturer and the processes. Maybe as follows:
1. Production Spec
2. Production itinerary
3. Manufacturing consistency
4. Territorial manufacturing plans
5. Anything that may effect future manufacturing
They would look at the human element:
1. Who can and cannot use the product
2. What is the training program
3. What is the method of support. Helpline, Online etc.
4. Who checks the checker etc.
Scientifically (this really is where I am treading water!) They would scrutinize the specific use in relation to the application. In this case breast cancer. The science would need to stand up in its own right. Any supporting evidence such as:
1. Academic research and studies
2. What is scientific, clinical or anecdotal. For instance if FDA decided that evidence submitted was anecdotal or of low scientific merit it would not be good.
Bottom line is that the application would need to stand up in all these aspects and more that I have not mentioned. As each FDA employee would be putting their name to something, that means they will only do so if they are convinced it will not come back and bite them in the bottom.
These are just my thoughts. They may be wide of the mark. Food for thought anyway. The good name of the FDA I would assume is what matters most to them.
FYI. I have not sold a bean here.
ATB
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