CASE STUDY BY THE FDA INDUSTRY COMPUTER SOFTWARE ASSURANCE (FICSA) TEAM

fda-csa-case-study

An AI/ML model-based solution remains at its core a software solution, albeit at a scale of model data sets and computational capacity previously unseen. It is based on a locked algorithm, which is defined by the FDA as “an algorithm that provides the same result each time the same input is applied to it and does not change with use.” CSA is required, focusing on baseline expectations rather than attaining 100% of acceptance criteria.