SPADA Docs

7.0 Creation of data and documentation for regulatory reviews 7.1 Emergency Use Authorization (EUA) Authority

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7.2 FDA Regulatory Pathways 7.2.1 Device Classification 7.2.2 The 510(k) Program

7.2.3 De Novo Classification Process 7.2.4 Premarket Approval (PMA)

8.0 Conclusions 9.0 Glossary

10.0 Acknowledgements

11.0 References

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1.0 Abstract/Objective: 28 In this document, we describe use of in silico approaches to improve molecular assay 29 development process and reduce the time and cost by utilizing available databases of whole 30 genome pathogen sequences combined with modern bioinformatics and physical modeling tools. 31 Well defined and well characterized assays are needed for accurately detecting pathogens in 32 environmental and patient samples and also for evaluation of the efficacy of a medical 33 countermeasure that may be administered to patients. The polymerase chain reaction (PCR) 34 remains the gold standard for pathogen detection due to the simplicity of its instrumentation, low 35 cost of reagents, and outstanding limit of detection, sensitivity, and specificity. However, 36 creation of such PCR assays often involves iterations of design, preliminary testing, and 37 thorough validation with clinical isolates and testing in relevant matrices, which can be time 38 consuming, costly, and result in sub-optimal assays. Since formal validation (e.g., for Emergency 39 Use Authorization or Food and Drug Administration licensure) of an infectious disease assay can 40 be very expensive and may require 6 months to 12 months, having a well-designed assay upfront 41 is a critical first step. Yet, many assays described in the literature utilized limited design 42 capabilities and many initially promising assays fail the validation process, resulting in increased 43 costs and timelines for successful product development. While the computational approaches 44

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