SPADA Docs

limited resources on potentially unnecessary redundant validations. Funding, development, and 741 implementation of such an assay stewardship approach is highly recommended by the SPADA 742 working group. 743 744 7.0 Regulatory Considerations for Nucleic acid-based Clinical Assays 745 Disclaimer : The content of this publication does not necessarily reflect the views 746 or policies of the Department of Health and Human Services, nor does the 747 mention of trade names, commercial products, or organizations imply 748 endorsement by the US government. This publication is not an official FDA 749 guidance or policy statement. 752 applications. In silico analysis approaches such as those outlined here, provide invaluable 753 information for facilitating development of molecular assays and, in some cases, provide unique 754 validation data in situations where wet testing is difficult. For example, in silico tools can 755 identify potential cross-reactive species that can be further validated in analytical testing to 756 determine the extent of cross-reactivity (i.e., concentration of microorganisms that can adversely 757 impact assay performance) which provides information on assay specificity or identify known 758 limitations (e.g., the extent to which closely related organisms can be differentiated). How in 759 silico tools are incorporated into the design, development and validation of an assay for clinical 760 use depends on multiple factors that include the scope of the Intended Use, technology of the 761 assay (e.g., IVD-nucleic acid-based test, etc.), test principal, and analyte(s) of interest. 762 Collectively these also inform the type of regulatory submission a developer/sponsor would 763 prepare for their device for FDA review prior to marketing. 764 750 751 In silico tools can be helpful for designing assays to address a wide range of clinical

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