The CDRH-NCIt terminology files provided here support the cooperative efforts of the Center 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 Data Standards and Terminology Standards for Information Submitted to CDRH web page.
CDRH terminology files are available for download from this NCI EVS ftp site (https://evs.nci.nih.gov/ftp1/FDA/CDRH/) in three formats:
FDA-CDRH_NCIt_Subsets.xls (Microsoft Excel)Each file has column headers on the first row:
| Spreadsheet Column | Content Description |
|---|---|
| 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. |
| CDRH 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. |
| NCIt Preferred Term | The NCIt preferred term attached to the concept. |
| NCIt Definition | A text definition of the term created by an NCI EVS subject matter expert. |
| CDRH Preferred Term | The CDRH preferred term attached to the concept. |
| CDRH Source Code | A 3 or 4 digit code generated by the CDRH. |
| CDRH Definition | A text definition of the term created by an FDA subject matter expert. |
| IMDRF Code | The code issued by the IMDRF (International Medical Device Regulators Forum). For more information see www.imdrf.org. |
CDRH terminology is bundled into subsets, identified by code and name in the first and second columns. These are the names and definitions of the subsets.
| Subset Name | Subset Description |
|---|---|
| CDRH Health Effect - Impact Code Terminology | Terms/codes for describing the consequences of the medical device adverse event/incident on the person affected used by the CDRH. |
| CDRH Health Effect - Clinical Code Terminology | Terms/codes for describing the clinical signs and symptoms or conditions of the affected person appearing as a result of the medical device adverse event/incident used by the CDRH. |
| CDRH Medical Device Problem Code Terminology | Terms/codes for describing problems (malfunction, deterioration of function, failure) of medical devices that have occurred in pre- or post-market contexts (e.g. clinical studies, clinical evaluation or post-market surveillance), used by CDRH. |
| CDRH Component Code Terminology | Terms/codes for describing the parts and components which were involved in, or affected by, the medical device adverse event/incident used by the CDRH. |
| CDRH Cause Investigation - Type of Investigation Terminology | Terms/codes for describing what was investigated and what kind of investigation was conducted to specify the root cause of the adverse event used by the CDRH. |
| CDRH Cause Investigation - Investigation Findings Terminology | Terms/codes for describing the findings in the specific investigation that are the keys to identify the root cause used by the CDRH. |
| CDRH Cause Investigation - Investigation Conclusion Terminology | Terms/codes for describing the conclusion of the device involved in the reported event used by the CDRH. |
Also included on the NCI EVS ftp site
(https://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 20.02d which corresponds to the year 2020, 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: 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:
https://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