FDA Terminology

The U.S. Food and Drug Administration (FDA) is working with Enterprise Vocabulary Services (EVS) to develop and support controlled terminology in several areas. NCI Thesaurus (NCIt) stores more than 28,000 FDA terms and codes. The FDA uses this and other terminology and makes it available for download via the NCI File Transfer Protocol (FTP). You can get FDA terminology subsets in each of these five main areas:

1. Structured Product Labeling (SPL) is a document markup standard that the Health Level Seven (HL7) approves. HL7 is an international medical standards organization that the FDA uses 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: You can download 44 sets of SPL terminology that NCIt maintains in Excel or text formats.
   • The Medication Reference Terminology (MED-RT™) is the successor to the Veterans Health Administration's National Drug File - Reference Terminology (VHA NDF-RT™). Both are formal ontological representations of medication terminology, pharmacologic classifications, and asserted authoritative relationships between them. You can get MED-RT monthly release files from NCI's EVS. 
      
2. Unique Ingredient Identifier (UNII) codes, which the FDA is developing, uniquely identify all ingredients 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 and updates them once a month. These codes are in corresponding NCIt concepts. You can download Excel and text files providing UNIIs with matching NCI concept codes.
    
3. Individual Case Safety Report (ICSR) terminology is terminology you can use encode adverse event information for reporting purposes. You can download fourteen ICSR term sets from NCIt in Excel and text formats.
    
4. Event Problem Code terminology is terminology that the Center for Devices and Radiological Health (CDRH) developed for reporting medical device problems. NCIt maintains seven CDRH term sets including: 
    
   • Medical Device Problem, Cause Investigation.
   • Type of Investigation, Cause Investigation.
   • Investigation Findings, Cause Investigation.
   • Investigation Conclusion, Health Effects.
   • Clinical Signs and Symptoms or Conditions, Health Effects.
   • Health Impact, Medical Device Component.

       You can download these term sets in Excel, text, and XML formats.
 

5. Global Unique Device Identification Database (GUDID) terminology is terminology that CDRH-GUDID developed to represent the attributes in the GUDID, which is 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. When there are new attributes, you'll find updated GUDID terminology. You can download Excel and text files of NCI-maintained GUDID terminology and codes.
    
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. You can download PQ/CMC terminology files from the NCI EVS FTP site in Excel, text, or XML formats.