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Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.
This is the first of a two-part series reviewing the basics of electronic medical device reporting.
The electronic Medical Device Reporting (eMDR) program allows for the electronic submission of mandatory medical device reports (MDRs), which are regulated under federal law (21 CFR 803). The eMDR program changes how reports are submitted—it does not change what is considered reportable or what information those reports should contain.
The electronic MDRs are sent in a standard format, specifically the Health Level Seven (HL7) v3 Individual Case Safety Report (ICSR) release 1 data model. Each type of MDR submitted (intial/30-day, 5-day, and supplements to already submitted reports) is sent using a single ICSR report.
There are two options for submitting MDRs electronically, and both options are available to all reporters.
The first option uses a combination of two tools, eSubmitter and WebTrader. This method of submission is similar to the process for paper submissions in that reports are created and submitted electronically one at a time. However, unlike paper submissions, this option provides the ability to store, submit, and retrieve reports electronically as well as providing acknowledgements for each stage of the report's transmission process. The tools used in this method are quite separate from each other so let's go over each as a separate component:
This option will be most useful for reporters who do not submit a lot of reports or still use the paper submission process. This solution is also the least costly since there is no cost associated with eSubmitter or having a WebTrader account (though a digital certificate is required at nominal cost for ESG account holders).
The second option is the direct/automated submission of reports in the required electronic format from a reporter's server to the FDA ESG, allowing reports to be submitted individually or as a batch (one electronic file containing any number of reports). For this option, the reporter uses the correct format for the report and submits an encrypted message directly to the ESG. The ESG submits any messages directly to the reporter. This option is particularly suitable for reporters that submit large numbers of reports or utilize a complaint handling system to manage MDR submissions. For those reporters utilizing complaint handling systems, they may find the vendor of the system has a module available that integrates electronic submission of MDRs to FDA into the already present complaint handling system.
In order to submit reports via the ESG, the reporter needs to obtain an ESG account. The process to do this can be grouped into six steps:
For WebTrader users, only a single test needs to be sent:
For the direct/automated method of submission to FDA, the following tests need to be sent:
And that's it!
Once the production account is approved, a reporter can begin to submit regulatory compliant MDRs to FDA via the ESG. Once a reporter begins to submit electronically it is best to submit all subsequent reports electronically.
Electronic submission of MDRs to FDA is a great way to submit since it allows for fast transmission, acknowledgement of the report's journey through FDA, and maintenance of MDRs and any records associated with them in electronic format.
Eugene Reilly is a public health analyst in FDA's Center for Devices and Radiological Health (CDRH) Office of Surveillance and Biometrics and works on the systems (and the policies that drive them) that process, display, and analyze medical device adverse event information. Additionally, he also maintains the CDRH Event and Evaluation Codes used in MDRs. Eugene began his career with FDA in the Office of In Vitro Diagnostic Device Evalution and Safety as a clinical reviewer and compliance officer. Prior to and during this time with FDA, he is a programmer focusing on XML, Python, and Java for databases, web-based applications, and computer graphics. He may be reached at (301) 796-6156 or Eugene.Reilly@fda.hhs.gov.
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