Collection of adverse event information on medical devices is mandated by Medical Device Reporting (MDR) requirements of the Food Drug and Cosmetics Act (FD&C Act) (21 USC 360i), and comes primarily from manufacturers, user facilities, importers and voluntary reporters. Currently a majority of these reports are entered manually by data entry contractors.
The electronic Medical Device Reporting (eMDR) project provides the capability for electronic data entry and processing of medical device adverse event reports. The project utilizes Health Level Seven (HL7) Individual Case Safety Report (ICSR) standard to receive medical device adverse events (MDRs). The eMDR application accepts electronic medical device reports via two options, designed for low and high volume reporters. Both options are open to all reporters.
(1) FDA eSubmitter – a free downloadable application that will allow submission of MDR reports one at a time. This option is suitable for low volume reporters. The software contains data elements from the current MedWatch and generates an HL7 ICSR message for each MDR the user generates using the software. See Technical Information on eMDR.
(2) Health Level 7 (HL7) Individual Case Safety Report (ICSR) – This option provides the capability to receive and process electronic MDR files either individually or as a batch and is particularly suitable for high volume reporters. Users of this option submit MDRs formatted as an HL7 ICSR message.
eMDR utilizes the FDA Gateway, an agency-wide entry point for all electronic submissions, to receive electronic MDRs. The Gateway authenticates and validates electronic submissions and routes it to CDRH. See the Electronic Submissions Gateway site to register as a trading partner. If you have any questions regarding the registration process or the Gateway in general, please contact the help desk as indicated on the website.
For further information, please write to eMDR@fda.hhs.gov.