eMDR - electronic Medical Device Reporting
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.
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. Please visit http://www.fda.gov/esg/ 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.
Updated December 18, 2007
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH