Product Jurisdiction Tool

The Center for Drug Evaluation and Research, specifically the Office of Executive Programs’ Product Jurisdiction Team, seeks contractor support to systematically catalog and organize decades of historic policy decisions and designations for both combination and non-combination products. Currently managed through unstructured email communications, these critical jurisdictional determinations lack a centralized, accessible system, leading to inefficiencies and inconsistencies in product classification. The contractor will be tasked with transforming this fragmented archive into a structured, searchable database that ensures reliable reference for future regulatory decisions and supports consistent application of product designations across the Center. The initiative aims to enhance predictability and efficiency in regulatory pathways by creating a durable digital tool that captures the rationale, context, and outcomes of past jurisdictional rulings. This tool will serve as a foundational resource for internal staff and external stakeholders, enabling faster, evidence-based decisions while reducing redundancy and misclassification risks. The work is being pursued under the NAICS code 541519, indicating professional, scientific, and technical services, and is being managed by the Food and Drug Administration’s CDER with a designated acquisition liaison available for inquiries, though the contracting officer position remains unfilled. The opportunity has been publicly forecasted, signaling the FDA’s intent to award a contract in the near future to support this important modernization effort.