Product Jurisdiction Tool

The Center for Drug Evaluation and Research (CDER), specifically the Office of Executive Programs (OEP) Product Jurisdiction Team, seeks contractor support to systematically catalog and organize its historic policy actions and designations regarding Combination and non-combination products. Currently, classification and jurisdiction decisions are maintained primarily through email, and this effort aims to create a more structured, accessible repository that will enhance efficiency, consistency, and predictability in future product designations and regulatory processes. This project, titled "Product Jurisdiction Tool," falls under the NAICS code 541519 and is managed by the Food and Drug Administration (FDA). Although specific contract details such as solicitation number and point of performance location have not been defined, the primary point of contact for program inquiries is the CDER Acquisition Liaison. The initiative reflects FDA’s focus on improving internal operational tools to support regulatory decision-making and ensure clear guidance on product jurisdiction matters.