Use the following files to assist in downloading, viewing, selecting the appropriate CDRH Manufacturer Evaluation Codes.
- CDRH has developed the Evaluation Code terminology for the reporting of medical device evaluations by the manufacturer. Three CDRH term sets, covering Evaluation Method Codes, Evaluation Result Codes, and Evaluation Conclusion Codes, are maintained in the NCI thesaurus (NCIt) and available for download in Excel, XML, and Text formats for importing into other applications. Text files describing both recent and upcoming changes are available here.
- When reporting a code to FDA, paper and eSubmitter users should use the 2 to 4 digit FDA code. AS2 submitters can use either use the 2 to 4 digit FDA code or the NCI concept code (the alphanumeric code with the format C##### that uniquely identifies each term in the NCI Thesaurus).
- Code Hierarchy Viewing files
- Evaluation Method Code Hierarchy - organizes the evaluation method codes as a hierarchical listing
- Evaluation Result Code Hierarchy - organizes the evaluation result codes as a hierarchical listing
- Evaluation Conclusion Code Hierarchy - organizes the evaluation conclusion codes as a hierarchical listing
- Evaluation Code Disposition File - An Excel file that lists all the FDA CDRH Evaluation Codes (organized alphabetically) and maps them to the improved Evaluation Codes. The file shows exactly what happened to each code and provides recommendations for selection of the improved term. The file also indicates which terms were inactivated as part of this project.
- 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 Device Problem Codes 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 the device problem codes in F.10. or the manufacturer evaluation result codes in 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.
The FDA resource files listed above will always contain the most up-to-date version of the CDRH Evaluation 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 - forindustry/datastandards/datacouncil Shows all FDA Data Standards Resources including FDA Terminology hosted by NCI Enterprise Vocabulary Services 21. 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.