FDA Questions

Greg Svanas 76325.2506 at compuserve.com
Mon Jul 17 13:48:17 EST 1995

DjayR at aol.com wrote:
>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 tests
>on humans?
>Thanks for the info.
>Jay Rothstein, Ph.D.
Any test developed for routine diagnostic use with humans in the US has 
to be approved by the FDA. Experimental diagnostics fall into a special 
category, but they are still regulated.  Not only the test needs to be 
approved, the manufacture of the test also has very strict requirements. 
 If the test fails, the manufacturer is responsible, but the FDA will 
ensure that appropriate steps are taken to prevent loss of life, etc.


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