FDA Questions

Bryan Kiehl b3748 at cts.com
Wed Jul 12 11:59:56 EST 1995

>>> Does anyone know if a newly developed PCR test needs FDA approval to get
>> remimbursed from insurance companies?  IF it is FDA approved and the test
>> fails who is responsible?  Is FDA approval required for all diagnostics 
>> on humans?
>> Thanks for the info.
>> Jay Rothstein, Ph.D.
If test kits are sold interstate (accross state lines) by a commercial 
company and are intended to be used for human diagnosis, then they do need 
some form of FDA review. If this is your intent, PCR is carefully regulated at 
FDA. I suggest that you call the office for small manufacturers. If needed, I 
could provide the number. This office is quite imformative.

It is not always clear what is needed if a lab performs a test method 
developed in-house. Today this is not typically under the review of the FDA, 
but reimbursement is a different matter. Additionally, medically liability is 
the concern of the kit manufacturer, laboratory and clinician and not usually 
related to FDA reviews.

Another problem you may also need to consider is liscensed used of PCR from 

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