[ RadSafe ] Radiobioassay and FDA Approval

[Clayton J Bradt]

Stan, what's the difference between "CLIA certification" and "FDA 
approval"?

Clayton J. Bradt
Principal Radiophysicist
NYS Dept. of Health
Biggs Laboratory, Room D486A
Empire State Plaza
Albany, NY 12201-0509

518-474-1993


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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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