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Posted On: 04/04/2018 6:07:07 PM
Post# of 9144
Re: rayludwiczak #4405
Hope an opinion is okay, none.
It’s been awhile since i’ve been doing any DD on this but back when BNP was the rage I concluded that at the very least the clean room or manufacturing facility would need FDA inspections for any product used for the purpose of diagnosing humans. We were informed (via MB rumor no doubt) that 510K wasn’t required to begin selling, depends what it’s used for it’s not, perhaps since the human eye determined outcomes it wouldn’t be needed? N-Assay i don’t know,
I can only imagine if I had a few lawyers looking over both shoulders it would seem prudent to insist on the above.
It’s been awhile since i’ve been doing any DD on this but back when BNP was the rage I concluded that at the very least the clean room or manufacturing facility would need FDA inspections for any product used for the purpose of diagnosing humans. We were informed (via MB rumor no doubt) that 510K wasn’t required to begin selling, depends what it’s used for it’s not, perhaps since the human eye determined outcomes it wouldn’t be needed? N-Assay i don’t know,
I can only imagine if I had a few lawyers looking over both shoulders it would seem prudent to insist on the above.
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