I think it's the first one but I'm not sure
Answer:A submitter of a premarket notification submission (510(k)) must demonstrate to the Food and Drug Administration (FDA) that the “new device” is “substantially equivalent” (SE) to a legally marketed predicate device. This guidance is intended to help 510(k) submitters demonstrate substantial equivalence. This guidance does not add new regulatory requirements for submitters, it does not change the 510(k) premarket review standard nor does it create extra or new burdens on what has traditionally been submitted in 510(k)s. FDA developed this guidance to improve the predictability, consistency, and transparency of the 510(k) premarket review process. Furthermore, this document is intended to serve as an aid for evaluating the benefit-risk profile of a new device in comparison to the predicate device.
Our lungs.
Hope this helps. c:
Fungal Parasites,
specifically basidiomycetes causes various infectious diseases that destroys
billions of dollars of food crops annually with worldwide impact. The 1972 U.S.
corn crop was almost completely destroyed by a fungus and during the late 1990s
most wheat fields in Arizona had to be devastated due to the existence of
fungal parasites. This clearly suggest that the presence of fungal
parasites resulted in loss or reduction of food crops.
Furthermore, basidiomycetes are
called club fungi, which is part of a <span>major group of fungi that produce a basidium
structure that includes mushrooms and toadstools. Although, they have economic
use in pharmaceutical industry such as producing penicillin and provide us food
like cheese, mushroom, in baking and in brewing, there negative impact must
also be consider and should be handle appropriately to eradicate crop
destruction.</span>
Because the land masses are getting closer not further apart
