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U.S. Department of Health and Human Services

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Individual Case Safety Reports

The Individual Case Safety Report (ICSR) is a Health Level Seven standard for the capture of the information needed to support the reporting of adverse events, product problems or consumer complaints associated with the use of FDA regulated products. The HL7 ICSR will be used as the FDA baseline data exchange standard, and is currently being pilot tested to support FDA’s transition to a unified electronic environment for managing all FDA-regulated product information for adverse event reports, product and consumer complaints and product problem reports.

HL7 ICSR Release 1 was approved as an ANSI Standard in 2005, and is being piloted to support electronic medical device reporting (eMDR) for the FDA Center for Devices and Radiological Health (CDRH). Information about eMDR can be found at: eMDR – electronic Medical Device Reporting

ICSR Release 3 provides support for adverse event reporting for all FDA regulated products. It is currently being balloted as an SDO Joint Initiative between three standards development organizations CEN, HL7 and ISO. Information about the SDO Joint Initiative is found at: http://www.global-e-health-standards.org/. ICSR Release 3 schema and other documents will be made available on this site in the future. Please note that FDA is not accepting comments to the official SDO ballot through this website. Formal ballot comments should be sent to the appropriate SDO for review and reconciliation.

ICSR Release 3 replaces HL7 ICSR Release 2 Draft Standard for Trial Use approved by HL7 in January 2007. FDA does not recommend implementation of ICSR Release 2 because the content will be deprecated with ICSR Release 3.

 

ICSR Documents

HL7 Individual Case Safety Report Release 1: Implementation Guide for FDA Medical Device Reporting

 

ICSR Schema

FDA ICSR Schema for Implementation (ISO 27953-1 compliant.) (Zip file last updated June 22, 2012)

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