eMDR – Electronic Medical Device Reporting

Posted on March 6, 2012. Filed under: Uncategorized |

About the eMDR Program

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 (formerly CeSub) – FDA eSubmitter is 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. For more information, please go to FDA eSubmitter: Electronic Medical Device Reporting (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. For more information, please go to Health Level Seven (HL7) Individual Case Safety Reporting.

For further information, please write to eMDR@fda.hhs.gov.

For information concerning the August 21, 2009 eMDR Notice of Proposed Rule Making, please write toSteve.Chasin@FDA.HHS.GOV or call 301-796-6053.

Need to send a guidance compliant electronic MDR submission?

eMDR utilizes the FDA Electronic Submissions 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. After registering with the FDA Electronic Submissions Gateway as a trading partner, one of the requirements for an ESG production account is to submit a guidance compliant submission to CDRH. The purpose of testing is to catch any issues early on, so once you transition to electronic reporting, there are no major problems due to improper formatting or incorrect values in the submission. When you are ready to send a guidance compliant electronic MDR submission, please send the below (based on your submission method) to the test ESG account.

For High Volume/B2B/AS2 Partners:

If a particular report does not apply to your situation, please discuss with an eMDR team member.

  • A complete Initial 3500A
  • A complete Initial 3500A with an attachment
  • A complete Initial 3500A followed by a supplemental 3500A (supplemental to be submitted after initial is loaded successfully)
  • A complete Initial 3500A with section F filled out (section F is used to provide information from user facility or importer source report)
  • A complete Initial 3500A and source report(s)

For Low Volume/WebTrader users:

  • A complete Initial 3500A

Once you have your electronic MDR as determined by your submission method above, please send an email to eMDR@fda.hhs.gov with the report number and core-id from the third acknowledgement. Once CDRH verifies the submission(s) are loaded into the FDA database properly, we will notify the ESG to give you a production account.

For more technical information please see the Technical Information on eMDR.

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