Centers for Devices and Radiological Health (CDRH) Terminology Files

The CDRH-NCIt terminology files provided here support the cooperative efforts of the Centers for Devices and Radiological Health (CDRH) and the National Cancer Institute's Thesaurus (NCIt) to develop terminology that facilitates the processing and review of device data. The efforts are described more fully on the CDRH Event Problem Codes web page.

CDRH terminology files are available for download from this NCI EVS ftp site (http://evs.nci.nih.gov/ftp1/FDA/CDRH/) in three formats:

FDA-CDRH_NCIt_Subsets.xls (Microsoft Excel 2003)*
FDA-CDRH_NCIt_Subsets.txt (Tab-delimited text)
FDA-CDRH_NCIt_Subsets.xml (xml)

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 Code A 3 or 4 digit code generated by the CDRH.

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 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.

CDRH terminology is bundled into subsets, identified by code and name in the second and third columns of each row. These are the names and definitions of the subsets.

Subset Name Subset Description

FDA Center For Devices and Radiological Health Terminology This is the top node of the CDRH hierarchy.

Medical Device Component Or Accessory Terminology FDA CDRH Terminology of medical devices or accessories.

Medical Device Problem Codes FDA CDRH Terminology created to describe medical device problems.

Patient Problem Codes FDA CDRH Terminology created to describe patient problems.

Medical Device Evaluation Conclusions Terminology FDA CDRH Terminology that represents conclusions of evaluations used by the CDRH with respect to reporting Medical Device events.

Medical Device Evaluation Methods Terminology FDA CDRH Terminology that represents methods of evaluations used by the CDRH with respect to reporting Medical Device events.

Medical Device Evaluation Results Terminology FDA CDRH Terminology that represents results of evaluations used by the CDRH with respect to reporting Medical Device events.

Also included on the NCI EVS ftp site (http://evs.nci.nih.gov/ftp1/FDA/CDRH/) are the following additional files:

About (This file)
Changes.txt (A text file of changes between the most recent and the current version of CDRH terminology. For each change record, the Changes.txt contains a complete row of tab delimited data with the same data elements as described above. An "A" will precede any new concept additions, a "C" will precede any modification to existing concepts, and a "D" will precede any concepts that have been deleted.)
Version.txt (A text file that contains the version of NCI Thesaurus that corresponds to the current spreadsheet data. The database is reconciled the last Monday of every month. The files will be posted during the following two weeks. The version appears as YR.MOweek. An example is 11.02d which corresponds to the year 2011, the month of February, and the "d" refers to the fourth Monday of the month.)

N.B.: If there are no changes to the data for a particular month, the files will not be reposted. An update via the LISTSERV will be sent with this information.

Contact Information and Updates: Additional terms may be suggested at the Requesting a New Code page.
An NCI EVS CDRH Data Terminology LISTSERV has been created for end users' questions and for update notifications. Please visit the following link to sign up for the LISTSERV and search for ncievs-cdrh-terms-L .

Archived files are available at:
http://evs.nci.nih.gov/ftp1/FDA/CDRH

Archive/ Directory of dated release versions.

Help requests on these files should go to NCIThesaurus@mail.nih.gov

* If an attempt to view the Excel spreadsheet results in a page of nonsense characters, check the security settings in Excel to permit viewing. This is achievable by clicking the highlighted bar above the data, but below the menu bar in the spreadsheet.

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 Code	A 3 or 4 digit code generated by the CDRH.
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 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.

Subset Name	Subset Description
FDA Center For Devices and Radiological Health Terminology	This is the top node of the CDRH hierarchy.
Medical Device Component Or Accessory Terminology FDA CDRH	Terminology of medical devices or accessories.
Medical Device Problem Codes FDA CDRH	Terminology created to describe medical device problems.
Patient Problem Codes FDA CDRH	Terminology created to describe patient problems.
Medical Device Evaluation Conclusions Terminology FDA CDRH	Terminology that represents conclusions of evaluations used by the CDRH with respect to reporting Medical Device events.
Medical Device Evaluation Methods Terminology FDA CDRH	Terminology that represents methods of evaluations used by the CDRH with respect to reporting Medical Device events.
Medical Device Evaluation Results Terminology FDA CDRH	Terminology that represents results of evaluations used by the CDRH with respect to reporting Medical Device events.