FDA Terminology

The FDA is working with EVS to develop and support controlled terminology in several areas. More than 10,000 FDA terms and codes are stored in NCI Thesaurus (NCIt). This and other terminology used by FDA is updated and made available for download from an NCI File Transfer Protocol (FTP) site. FDA terminology subsets are available in each of these four 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 FDA to exchange medication information. The SPL standard specifies use of some 30 sets of controlled terminology. The NCI FTP site provides these SPL resources:
   • NCIt SPL Subsets: Eleven sets of SPL terminology are maintained in NCIt and available for download in Excel or text formats. SPL represents countries with ISO 3166-1 Alpha-3 country codes, extracted from NCIt in separate Excel and text files.
   • NDF-RT SPL Subsets: The VHA National Drug File Reference Terminology (NDF-RT) maintains terminology used to code these medication properties:
     • Mechanism of Action (Excel or text),
     • Physiologic Effect (Excel or text), and
     • Structural Class (Excel or text).
   • Problem List Subset: The Medical Condition component of SPL is coded with the VHA and Kaiser Permanente (VA/KP) Problem List Subset of the Systematized Nomenclature of Medicine Clinical Terms (SNOMED-CT). This set of SNOMED terms and codes is freely reusable worldwide without licensing or intellectual property restrictions. It is available in Excel, zipped Excel, and text formats, as well as through a specialized browser application.
2. Unique Ingredient Identifier (UNII) codes are being developed by 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. FDA provides a full set of published UNII codes and a search page on a Web site now hosted by the National Library of Medicine (NLM) and updated approximately monthly. These codes are also being included in corresponding NCI Thesaurus 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 NCI Thesaurus, and are available for download in Excel and text formats.
4. Center for Devices and Radiological Health (CDRH) has developed the Event Problem Code terminology for reporting of medical device problems. Three CDRH term sets, covering Patient Problem Codes, Device Component Codes, and Device Problem Codes, are maintained in NCIt and available for download in Excel, XML and text formats.