Now i am really confused. My understanding is if the product you are making now or will be
physically for sale on the market here within 90 of publication of the regs in the Federal Register
you are automatically grandfathered ( a word along with substantially I am beginning to hate)
into the pre-market approval process with the 2 year application time limit. The 90 day
time limit introduces all under age sales restrictions and requires new products introduced
after 90 days to to remain off the market until approved by the FDA as being compliant with
the regulations.(no grace period after 90 days)
I haven't read the whole 499 pages yet but,I have seen some quotes posted here
from parts I haven't read that are in direct contradictions of what is stated in parts
that I have read. If i can recall specifics I will point them out here. As i recall after the
proposed deeming regs were released there were more than a few confusing and or
definite contradictory statements. This seems to be the case with the release of the
official release. In hindsight I believe then and now this is a deliberate tactical ploy to
sew confusion in our ranks and split us into different factions fighting for different
things. If it is not a deliberate ploy the only other thing that would account for
this lack of cohesion is it is a deliberate tactical ploy to sew confusion in our ranks
and split us into different opposing factions. If anyone notes these types of contradictions
please point them out here so we can hash them out.

Regards
Mike
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