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, 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 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 accepts the following standard formats for clinical trial data. 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.
For information on submitting pre-market clinical data to CDRH electronically, see the February 2012 Draft Guidance for Industry Providing Regulatory Submissions in Electronic Format — Standardized Study Data.
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.
Device Identification: CDRH accepts the following standard format for device identification:
- Structured Product Labeling (SPL) – CDRH plans to use the HL7 SPL Release 5, Draft Standard for Trial Use (DSTU), to receive Device Identification (DI) information for the Global Unique Device Identification Database (GUDID), part of the Unique Device Identifier (UDI) system.
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. There are three types of event problem codes, and they are 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.