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7.2.4 Premarket Approval (PMA)

A device may be classified in class III and be subject to premarket approval (PMA) via 901 several different regulatory vehicles. In accordance with the criteria at section 513(a)(1)(C) of 902 the FD&C Act, FDA may promulgate a regulation classifying, or issue an order reclassifying, a 903 device type into class III based on the risks posed by the device and the inability of general and 904 special controls to provide reasonable assurance of the safety and effectiveness of the device. All 905 particular devices of this type are considered to be in class III. Further information on the PMA 906 process can be found on the Agency’s website (46, 47). 910 stages of assay design and relies heavily on wet lab testing for optimization and validation of 911 assay designs. Because of the multiple iterations of wet lab testing needed, this approach is 912 arduous, costly, time consuming and may result in suboptimal assays. 913 The modern assay development pipeline proposed here relies heavily on extensive in silico 914 approaches upfront using a variety of bioinformatic tools and well curated genome sequence data 915 bases to design robust assays and guide wet lab testing. Thus, this process reduces the time and 916 cost involved in developing new molecular assays or improving old assays by minimizing wet 917 lab testing guided by in silico results. 918 We describe best practices for wet lab testing and validation of molecular assays for 919 diagnostics application and monitoring of assay degradation over time due to signature erosion. 920 907 908 8.0 Conclusions 909 Traditional molecular assay development pipeline involves in silico process only in early

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