The U.S. Food and Drug Administration (FDA) is working with Enterprise Vocabulary Services (EVS) to develop and support controlled terminology in several areas. More than almost 25,000 FDA terms and codes are stored in NCI Thesaurus (NCIt). This and other terminology used by the FDA are updated and made available for download via the NCI File Transfer Protocol (FTP). FDA terminology subsets are available in each of these five main areas:

  1. Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7), an international medical standards organization, and used by the FDA to exchange medication information. The SPL standard specifies the use of some 42 sets of controlled terminology. The NCI FTP site provides these SPL resources:

    • NCIt SPL Subsets: 42 sets of SPL terminology are maintained in NCIt and available for download in Excel or text formats.

    • MED-RT SPL Subsets: The Veterans Health Administration (VHA) National Drug File Medication Reference Terminology (MED-RT) maintains terminology used to code these medication properties:

  2. Unique Ingredient Identifier (UNII) codes are being developed by the FDA to uniquely identify all ingredients used in marketed medications in the United States, as well as substances in biologics, foods, and devices. Each UNII is assigned based on molecular structure or other immutable characteristics. The FDA provides a full set of published UNII codes hosted by the National Library of Medicine (NLM) and updated approximately monthly. These codes are also being included in corresponding NCIt concepts, and files providing UNIIs with matching NCI concept codes are available for download in Excel and text formats.

  3. Individual Case Safety Report (ICSR) terminology is used to encode adverse event information for reporting purposes. Fourteen ICSR term sets are maintained in NCIt, and are available for download in Excel and text formats.

  4. Event Problem Code terminology was developed by the Center for Devices and Radiological Health (CDRH) for the reporting of medical device problems. Seven CDRH term sets (Component Codes, Health Effect–Clinical Codes, Health Effect Impact Codes, Investigation Conclusions, Investigation Findings, Medical Device Problem Codes, and Type of Evaluations) are maintained in NCIt and available for download in Exceltext and XML formats.

  5. Global Unique Device Identification Database (GUDID) terminology was developed by CDRH-GUDID to represent the attributes found in the GUDID, a repository of key device identification information related to a device's Unique Device Identifier. Labelers wanting to submit their device information using SPL format (and the FDA Electronic Submissions Gateway) will find all the necessary codes in this terminology. Through the use of the shared document standard, the GUDID terminology may share some codes with the SPL terminology listed separately on this page, but the SPL terminology does not contain all necessary device-related terms for GUDID. The GUDID terminology will be updated as new attributes are developed. The GUDID terminology and codes are maintained in NCIt and available for download in Excel and text formats.

  6. NCIt-Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) terminology files support the cooperative efforts of the FDA and the NCIt to develop terminology that facilitates the processing and review of Pharmaceutical Quality/CMC terminology files data. PQ/CMC terminology files are available to download from the NCI EVS FTP site in Excel, text, or XML formats.

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