FDA, patent, e-test

[Chong Wai Yin( Zhang Weixian)]

Hi, I'm wondering..... Is it necessary for ALL biological products eg.
Diagnostic kits to be approved by FDA before it can be marketed in the
States? If not, under what circumstance does the approval by FDA is not
needed.

Also, is anyone familiar with the patenting process for the US Department of
Commerce patent and Trademark Office? Eg. Need how $$ to open a file .....
etc.

Lastly, does anyone have any idea how is the E-test for detecting MRSA
priced? Eg. 100 strips cost ???

Thanks for your help.

Regards,
Kelvin