FDA Questions

DjayR at aol.com DjayR at aol.com
Mon Jul 10 13:44:05 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 tests
on humans?
Thanks for the info.

Jay Rothstein, Ph.D.

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