Non-NADA methods

The non-NADA method trial process mirrors the NADA process. Methods are developed, reviewed for scientific and technical soundness, and validated in multiple laboratories, and the data generated are analyzed to determine if the method is suitable for its intended use. 

The method trial process for NADA methods is different to the process for non-NADA methods. However, the validation protocol followed by the participating laboratories and the requirements for acceptance of the method are the same. The trial process also differs for determinative procedures and confirmatory procedures. Determinative procedures are evaluated using the multiple laboratory process, whereas the confirmatory method needs to be evaluated only in a single government laboratory. 

The FDA coordinates the method trial process for non-NADA methods. The sample requirements are the same as for the NADA trials. Non-Federal laboratories such as contract laboratories and State laboratories can participate in the process. For a single-residue method, the minimum numbers of samples and laboratories are the same as for NADA method trials. 

Non-NADA methods may be designed to detect multiple residues and they may be designed for use in multiple species. In order to validate these multi-residue methods, modifications to the validation protocol relative to single analyte methods are made. Additional laboratories will participate in the method trial, but the number of samples... 

Guidelines for acceptability of NADA and non-NADA methods are the same. For the determinative procedure, the criteria described in Method Criteria for accuracy and precision are used to evaluate data generated at participating laboratories. There are no criteria for accuracy in the analysis of the incurred residue samples however, the overall data set is reviewed to see if there is general agreement between results obtained by contract laboratories and relative to the levels reported in the sponsor s laboratory. 

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