The Investigations Operations Manual (IOM) is the primary operational reference for FDA employees who perform field activities in support of the agency’s public health mission. Accordingly, it directs the conduct of all fundamental field activities. Adherence to this manual is paramount to assure quality, consistency, and efficiency in field operations.

Other FDA manuals and field instructions supplement, but do not supersede, the information in this manual. We recognize this manual will not address all situations encountered in the performance of field activities. In such cases, your division management must be informed and concur with any significant departures from the IOM.

The 2023 version of the IOM contains important changes which clarify or present new information and procedures. As with each new edition of the IOM, please take time to review sections of the manual for changes which may apply to your work. Additions to the IOM are highlighted in light gray.

The IOM is also posted on ORA’s Internet Website, with all graphics included.

In 2022, the IOM Refresh Project continued its cover to cover, all-inclusive review of the IOM in an effort to ensure the manual presents information in a clear and useful manner for field and operational staff. This year saw the addition of two brand new chapters to the IOM: Chapter 1A – Notes, Records and Information and Chapter S – Safety and a refresh of Chapter 4 – Sampling. Chapter 1A updated information related to the use of electronic regulatory notes, added information about situations where CSOs are unable to take contemporaneous regulatory notes, and added a new section on records management. Chapter S serves as a tool to help employees understand, assess, and mitigate risk and hazards; an essential task to ensure the safety and well-being of all staff who meet with regulated industry. Another big change this year was the release of the Reagan-Udall reports for Foods and Tobacco. The reports show an opportunity for FDA to further evolve. ORA has always been on the forefront of evolution and 2023 will be no different. ORA stands on the edge of change and we will forge FDA’s new and exciting future.

The IOM is published hard copy annually. Until the IOM Refresh Project is completed, future updates to the IOM will continue to be performed periodically during the year to the online version. The online IOM version serves as ORA’s official document of record. ORA leadership is committed to continuously improving the quality and usefulness of the IOM. Suggestions for the 2024 edition of the IOM including recommended changes, deletions, and additions to the IOM may be sent via email to IOM@FDA.HHS.GOV. Suggestions are accepted from within the agency, our state and local partners, industry and consumers. All changes are reviewed by the IOM Committee, which is composed of a crossfunctional group consisting of representatives from each commodity area in addition to imports, recalls, and policy.