The CDRH-GUDID-NCIt terminology files provided here support the cooperative efforts of the Centers for Devices and Radiological Health (CDRH) Unique Device Identifcation (UDI) Program and the National Cancer Institute's Thesaurus (NCIt). Within the UDI Rule, FDA has the authority to require submission of key device attributes, along with the device identifier (DI) to the GUDID. All GUDID attributes and lists of values can be found in the CDRH-GUDID-NCIt terminology files.
CDRH-GUDID terminology files are available for download from this NCI EVS ftp site (http://evs.nci.nih.gov/ftp1/FDA/CDRH/GUDID) in three formats:
Each file has column headers on the first row:
|Spreadsheet Column||Content Description|
|Source||The initials of the requesting agency, in this case, the FDA.|
|NCIt Subset Code||The NCIt concept code attached to the subset concept. NCIt Codes are unique strings that begin with a C and are followed by a series of digits.|
|FDA Subset Name||The name of the subset.|
|NCIt Concept Code||The NCIt concept code attached to the concept. NCIt Codes are unique strings that begin with a C and are followed by a series of digits.|
|FDA Source PT||The preferred term attached to the concept.|
|FDA Source Synonym(s)||FDA terms considered synonomous to the concept's preferred term.|
|FDA Source Definition||A text definition of the term created by an FDA subject matter expert.|
|NCIt Definition||A text definition of the term created by an NCI EVS subject matter expert.|
Also included on the NCI EVS ftp site (http://evs.nci.nih.gov/ftp1/FDA/CDRH/GUDID) are the following additional files:
Contact Information and Updates: For questions about GUDID terminology, definitions or use in HL7 SPL submission, please contact the UDI Helpdesk.
Archived files are available at:
Help requests on these files should go to NCIThesaurus@mail.nih.gov