Signal detection using change point analysis in postmarket surveillance

This is the authors' abstract. We don't add key points for this paper.

As a complimentary tool to current signal detection efforts at FDA, CPA can be used to detect changes in the association between medical products and adverse events over time. Detecting these changes could be critical for public health regulation, adverse events surveillance, product recalls, and regulators' understanding of the connection between adverse events and other events regarding regulated products.