FDA, patent, e-test

Tim Spahlinger txs at po.cwru.edu
Fri Feb 25 14:58:19 EST 2000

All kits that are intended to be used for diagnostic purposes (i.e.,
establishing a diagnosis and/or monitoring a disease in a human) must be
approved by the FDA before it can be routinely used for such purposes.  The FDA
can issue exemptions that allow the manufacturer to offer the prospective
diagnostic kit on a limited basis for the intention of collecting data in
support of achieving the FDA's approval for the kit to be used for diagnostic
purposes (i.e., these are sometimes called "clinical trials").  One exemption is
referred to as an "Investigational Device Exemption".  I would advise you to
consult someone who has had experience in this before trying to proceed on your

As for your question pertaining to the patenting process in the US, I would
advise you to hire a US patent attorney (a "lawyer" that specializes in patent
law) because the process and the US law can be rather complex.

"Chong Wai Yin( Zhang Weixian)" wrote:

> 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

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