[ RadSafe ] Radiobioassay and FDA Approval

Stan Morton stan.morton at gel.com
Thu Mar 1 11:41:16 CST 2012

Dr. Pendergrass has requested that I share my thoughts on the need for CLIA
certification and FDA 'approval' as a radiobioassay laboratory. 
It is my personal opinion that the analysis of excreta material is only a
part of the dose-evaluation process.  As long as the laboratory reporting
the analytical results does not provide a dose estimate, there is no reason
to require FDA 'approval' should it exist.  It should be understood that the
laboratory be required to participate in the appropriate
performance-evaluation programs (i.e., DOELAP, NAVLAP, Oak Ridge, etc.) that
determine ability to provide an acceptable result.  I agree the laboratory
should be CLIA certified. 
Most HP/MDs that provide dose estimates employ computer programs as part of
the process, i.e. IMBA , DCAL, etc.  I know of no program within the FDA
that has the ability to evaluate these codes, or do I know of a program
within FDA that can issue 'approval' to an analytical laboratory to perform
radiobioassay work.  In fact, I know of no program in any form that
evaluates the entire dosimetric assessment process.  One can see a need. 
Stan Morton
Manger, Radiobioassay Programs
GEL Laboratories 

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