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OMB Expectation Parameters
Method
Applicability
Safety
Concerns
Reference
Materials
Must be clearly
written and meet
user needs
ERP
recommendations
Safety review
needed prior to
First Action status
All concerns must
be addressed
Source reference
materials
Alternatives if
implemented
Assess method
limitations and
concerns
within tracking
period
none available?
Single Laboratory
Reproducibility/
Comparison to
/
OMB Expectation Parameters
Validation
Qualitative methods: inclusivity
(or equivalent), exclusivity (or
equivalent), robustness,
repeatability, POD (or equivalent),
cross reactivity, matrix scope,
etc…
Uncertainty
Qualitative methods: ‐ probability
of detection or equivalent
Standard
Acceptance Criteria
Documented method
performance versus a SMPR,
recognized reference standard
(materials), recognized reference
method, or general method end
user community guidance and/or
acceptance criteria
Quantitative methods:
demonstrated method linearity,
accuracy, repeatability,
selectivity, LOD/LOQ, Matrix
scope, etc….
Quantitative methods:
demonstrated method
reproducibility and/or uncertainty
Document reasons for
acceptability if it doesn’t meet the
standard or acceptance criteria