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  6. eMDR – Electronic Medical Device Reporting
  1. Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities

eMDR – Electronic Medical Device Reporting

eMDR News

Electronic Medical Device Reporting (eMDR)

On Feb. 13, 2014, the FDA published a final rule on Electronic Medical Device Reporting (eMDR) that requires manufacturers and importers to submit MDRs to the FDA in an electronic format that the FDA can process, review, and archive. User facilities can also submit eMDR reports, but the final rule allows user facilities to continue to submit paper MDR reports.

Manufacturers and importers had until Aug. 13, 2015 to begin submitting all MDR reports electronically. If a manufacturer or importer was unable to meet this date, they must request and obtain an exemption from electronic reporting to continue to report via hardcopy past Aug. 13, 2015.

The FDA also released a Guidance for Industry, User Facilities and FDA Staff "Questions and Answers about eMDR- Electronic Medical Device Reporting" to answer questions related to FDA’s final rule requiring device manufacturers and importers to submit mandatory MDRs electronically.

Submitting to eMDR

The FDA has two options for manufacturers and importers to electronically submit MDRs:

  1. Web Interface using the eSubmitter application
  2. AS2 Gateway-to-Gateway using HL7 ICSR XML

The Electronic Submissions Gateway (ESG) is an agency-wide entry point for all electronic submissions, including eMDRs. The ESG functions as a single point of entry for the receipt and processing of all electronic submissions in a secure environment that complies with secure messaging standards.

Submitters using the ESG web interface are required to download eSubmitter, create a MedWatch 3500A electronic submission zip file using eSubmitter, and log into the WebTrader internet site to submit the file.

Submitters using the AS2 gateway interface will be required to develop or purchase an AS2 submission system capable of generating HL7 ICSR XML and transmitting it to the ESG.

Both options are open to all reporters.

Enrolling in the eMDR Program

Reporters who do not currently hold an ESG production account will be required to sign up for a pre-production account with the ESG. A helpful checklist for obtaining an ESG account is available on the ESG website. Once they are granted a pre-production account, reporters will be asked to perform a series of test submissions required by the ESG.

Note: Manufacturers seeking to submit MDRs for devices available under an Emergency Use Authorization (EUA) or following an Enforcement Policy Guidance for a COVID-19-related medical device may find useful the additional information discussed in Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or the relevant COVID-19-Related Guidance Document.

New reporters who have completed the ESG pre-production tests, and those reporters who already have an ESG production account, will be required to complete one or more guidance-compliant test submissions to eMDR in the pre-production environment. These tests are required for all reporters before submitting to the production eMDR system.

For more information, see: How to Enroll in eMDR Program.

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