Coding Tools / Resource Files

Use the following files to assist in downloading, viewing, selecting the appropriate CDRH Event Problem Codes.

The following 25 Component Codes still exist as part of the code enhancements; HOWEVER, please note changes to the FDA code numbers. All code changes are reflected in all the Resource Files. For these codes only - the old FDA code numbers will be not be accepted after July 1, 2009.

• Download file – Excel file containing all CDRH Event Problem Codes (Patient Problem, Device Problem and Component Codes); use for importing into other applications.
  • Download File
     
• Code Hierarchy Viewing files
  • Patient Problem Code Hierarchy - organizes the patient problem codes as a hierarchical listing
  • Device Problem Code Hierarchy - organizes the device problem codes as a hierarchical listing
  • Component Code Hierarchy - organizes the component codes as a hierarchical listing
     
• Patient Problem Code Disposition File - An Excel file that lists all the FDA CDRH Patient Problem Codes and terms (organized alphabetically) and maps to the improved Patient Problem Codes. The file shows exactly what happened to each code and provides recommendations for selection of the improved term, known as the "Preferred Term".The file also indicates which terms were inactivated or newly created as part of this project.
  • Also available split out in single Excel sheet form for accessibility: All Patient Problem Descriptions, Inactivated & Description Change, New Patient Problem Codes.
     
• Device Problem Code Disposition File - An Excel file that lists all the FDA CDRH Device Problem Codes and terms (organized alphabetically) and maps to the improved Device Problem Codes. The file shows exactly what happened to each code and provides recommendations for selection of the Preferred Term. The file also indicates which have been inactivated as part of this project.
  • Also available split out in single Excel sheet form for accessibility: All Device Problem Descriptions, Inactivated & Description Change.
• Component Code Disposition File – CDRH has updated the list of components used in medical device reporting (MDR). These components can be found as new Component Codes for entry on MedWatch Form 3500A, Field F.10. and as updates to the 'component' section of the H.6. Manufacturer Evaluation Results Codes. Note: the component codes listed in each of these sections are now exactly the same and can be used to report component information in either F.10. or H.6. of the MedWatch 3500A Form. To see what has changed, please see the Component disposition file which includes FDA code # changes, new codes, as well as inactivated codes.

For further details about the HL7 ICSR and for submitting all vocabulary items using HL7 ICSR, please refer to the CDRH Electronic Reporting website. 

Supplemental Sources

The FDA resource files listed above will always contain the most up-to-date version of the CDRH Event Problem Codes. The following links to NCI vocabulary are provided for those who wish to explore more detailed information about the terms – e.g. synonyms, NCI code information, etc.

Note: While in the transition period between existing and improved coding systems, please expect significant differences between codes stored in the NCI databases and those referenced in FDA CDRH files.

FDA Data Council – Shows all FDA Data Standards Resources including FDA Terminology hosted by NCI Enterprise Vocabulary Services. This includes the CDRH Event Problem Codes.

NCI Thesaurus - Scroll down the webpage and click on CONNECT button to enter the thesaurus. Enter 'FDA Center for Devices and Radiological Health Terminology' in the initial search box to see all CDRH Event Problem Codes. You may also enter an individual code.

NCI Metathesaurus – To see all CDRH Event Problem Codes, enter ‘FDA Center for Devices and Radiological Health Terminology’ in the initial Search box to see all CDRH codes. You may also enter a known code description. The metathesaurus is similar to the NCI Thesaurus except it also shows a mapping of the particular term to other terminologies including MedDRA, ICD-9 etc. Mappings to other terminologies are located in the ‘Sources section’ that appears as part of the coding entry. Also included on the page are: Synonyms, Definitions, Concepts more general, Concepts more specific and Concepts related to the selected term. Note that the metathesaurus contains many terminologies so it may be more difficult to use than the NCI Thesaurus.