FDA has published the revised Integration of the FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations (ConOps 2.0), which took effect October 21, 2026. This document outlines how the Center for Drug Evaluation and Research (CDER) and the Office of Inspections and Investigations (OII) coordinate marketing application assessment, inspections, and related compliance activities. ConOps 2.0 covers preapproval, postapproval, surveillance, and for-cause inspection processes.
ConOps 2.0 replaces the original version published in June 2017 and includes the following major updates:
- Organizational Updates. ConOps 2.0 reflects the October 2024 FDA reorganization, updating roles, responsibilities, and office names throughout. The Office of Regulatory Affairs (ORA) is now the Office of Inspections and Investigations (OII), and offices within the Office of Pharmaceutical Quality (OPQ) have been updated accordingly.
- New Evaluation Tools. The revised ConOps formally incorporates Remote Regulatory Assessments (RRAs) and Mutual Recognition Agreement (MRA) inspection reports as recognized evaluation tools. RRAs support regulatory decision-making through remote records review or Remote Interactive Evaluations (RIE), while MRA inspection reports from regulatory partners can fulfill inspection requirements under section 510(h) of the Federal Food, Drug, and Cosmetic Act.
- Clarified Roles and Responsibilities. ConOps 2.0 provides greater clarity on CDER and OII roles across inspection types covered by this agreement, including updated classification workflows and defined timelines.
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