The Center for Devices and Radiological Health (CDRH) encourages manufacturers to use data and terminology standards in pre-market submissions and post-market reports for medical devices.
The FDA can review and analyze data and information more quickly when manufacturers and user facilities have used our standards.
This web page contains definitions and links to additional resources to assist the device industry, user facilities (hospitals and health care clinics) and clinical investigators in using the FDA’s data and terminology standards for the preparation of pre- and post-market submissions.
Definitions for Data and Terminology Standards
- Data Standards provide consistent meaning to data shared among different information systems, programs, and agencies throughout the product’s life cycle. These include representation, format, definition, structuring, tagging, transmission, manipulation, use, and management of data.
- Terminology Standards control terms and definitions used in submissions to the FDA. They are often used in combination with a data standard to aid in exchange and interpretation of data.
Clinical Trial Data: CDRH does not require the use of a specific format for clinical trial data. CDRH accepts clinical trial data in any format, including the following standardized formats. These formats were developed by the Clinical Data Interchange Standards Consortium (CDISC):
- Clinical Data Acquisition Standards Harmonization (CDASH) - Provides standardized fields to aid data collection at clinical investigative sites.
- Study Data Tabulation Model (SDTM) - Provides a standardized model for clinical study data tabulations.
- Analysis Dataset Model (ADaM) - Provides a standardized model for dataset analysis.
Adverse Event Reporting Data: CDRH accepts the following standard format for reporting adverse events:
- Individual Case Safety Report (ICSR) –The Health Level 7 (HL7) Individual Case Safety Report (ICSR) captures information about adverse events and product problems that are reported to public health, patient safety, and quality improvement organizations, or regulatory agencies. CDRH currently uses HL7 ICSR Release 1 to receive Medical Device Reports (MDRs) for the electronic Medical Device Reporting (eMDR) program. Submitters can create HL7 ICSR compliant adverse event submissions themselves or use FDA’s eSubmitter application. Terminology for all ICSR data elements will be maintained in the NCI Thesaurus.
Unique Device Identification: CDRH accepts the following standard format for submission of device information to the Global Unique Device Identification Database (GUDID):
- Structured Product Labeling (SPL) Release 5 – CDRH plans to use the HL7 SPL Release 5, Draft Standard for Trial Use (DSTU), as one mechanism to receive Device Identification (DI) information for the GUDID), part of the Unique Device Identifier (UDI) system. FDA will also offer a non-HL7 mechanism for DI submission to the GUDID. Terminology for all data elements will be maintained in the NCI Thesaurus.
- FDA-accredited Issuing Agencies – Under the UDI Rule, FDA/CDRH has accredited organizations to operate a system for the issuance of UDIs for medical device products.
Event Problem Codes - CDRH’s Event Problem Codes are used to describe device and patient problems attributed to an event involving medical devices or radiation-emitting products in medical device reports (MDRs). There are three types of event problem codes maintained in the National Cancer Institute (NCI) thesaurus (NCIt): Patient Problem Codes, Device Problem Codes, and Component Codes.
- Adverse Events - These terminology sets are currently used by device manufacturers and user facilities for describing adverse events and product problems in medical device reports (MDRs), as well as alternative summary medical device reports (ASR).
- Recalls and Corrections - In the future, these terminology sets will also be available for submitters of voluntary reports of corrections and removals (recalls) and voluntary complaints to describe issues involving a device.
Manufacturer Evaluation Codes – CDRH’s Manufacturer Evaluation Codes are used to describe a manufacturer’s evaluation of a device involved in an adverse event and product problem in medical device reports (MDRs). There are three types of manufacturer evaluation codes maintained in the NCI thesaurus (NCIt): Evaluation Method Codes, Evaluation Result Codes (which can be used in combination with the Device Component Codes described above), and Evaluation Conclusion Codes.
DUNS Number – Issued by Dun & Bradstreet, the DUNS number is a unique 9-digit identification number for each physical location of a business. DUNS numbering is implemented in Registration and Listing and GUDID to standardize the company name and physical address for more effective and efficient entity identification.
Global Medical Device Nomenclature (GMDN) – GMDN is a system of internationally agreed descriptors used to represent common device types for the purposes of grouping or categorization of individual medical devices. GMDN is implemented by GUDID as a required data element on each device record.
Unified Code for Units of Measure (UCUM) – UCUM is a code system intended to include all units of measures being contemporarily used in international science, engineering, and business. The purpose is to facilitate unambiguous electronic communication of quantities together with their units. UCUM is implemented by GUDID as units of measure for size and storage conditions; the GUDID subset of UCUM values can be found in the NCI thesaurus.
Please contact the CDRH Informatics team at [email protected] if you have any questions regarding device data standards and terminologies.
If you are planning to use standards in a pre-market submission, it may be helpful to request discussion of this topic in a pre-submission meeting with FDA.
- Study Data Standards Resources
- eCopy Program for Medical Device Submissions Guidance Document (PDF - 525KB)
- CDRH eSubmitter Resources