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AOAC Research Institute Policies and Procedures
© 2009 - AOAC Research Institute
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appropriate data submission and labeling, and assignment of the General
Referee/Topic Advisor to review data submitted by the Licensee.
Level 2 and 3 Reviews include, but are not limited to the following:
1)
Entirely new procedure.
2
Removal of a precaution statement or warning, depending on the importance
of the existing precaution.
3)
Modification to reagents such as changes in formulation, concentration,
phase (solid or liquid) or format.
4)
Modification to, and/or changing of detection or measuring
equipment/instrumentation and/or
5)
Addition or deletion of regents and/or measuring instrumentation
Matrix extensions.
Level 3 Reviews
- require submission of a Method Modification Review Form with
appropriate data submission and labeling, assignment of the General Referee/Topic
Advisor, and 2 Expert Reviewers to review data submitted by the applicant, and
independent testing.
More detailed information and guidance about the classification of changes to test
kits may be obtained from the AOAC Research Institute Managing Director. Ask for
the
Test Kit Definitions and Modifications Guideline.
7.3
Identical Multiple Modifications:
Identical modifications (regardless of modification level) to a series of related test
methods sharing a common platformmay be submitted as one Modification Review.
For example, if a Licensee has three PTM approved test kits: one for
Salmonella
,
one for
Listeria
genus, and one for
E.coli
; all based on PCR using the same
thermocycler platform and reagents. The Licensee may submit to one Method
Modification Review form that applies to all three if the modification applies to all
three methods. For example, the Method Developer may choose to modify the
same liquid reagent to a lyophilized reagent in each of the kits. The Licensee will be
assessed one Modification Review fee (appropriate to the modification level).
The Licensee must submit a Method Modification Review Form and all supporting
documents at the same time.
Licensees should contact the AOAC Research Institute to determine the
modification level and if the modifications can be considered identical. The AOAC-
RI will consult with the General Referee/Topic Advisor to determine the modification
level and applicability of this policy.
7.4
Approval of Modifications:
Licensees will be notified in writing when their modification(s) are approved. The
AOAC-RI website List of Approved Methods will be updated to reflect any new
claims.