FDA News

EtQ Announces Software for Electronic Submissions to the FDA

(May 13, 2007)-- EtQ has released the beta version of the EtQ Reliance eMDR Submission Tool, enabling Medical Device Manufacturers to electronically submit Medical Device Reports (MDRs) to the Food and Drug Administration (FDA).

EtQ Reliance for Medical Device is the leading Quality Management system, designed to identify, mitigate and prevent high-risk events using automation, integration, and collaboration. This methodology allows companies to electronically automate the quality process for medical device, and comply with quality and compliance standards, including those of the FDA.

Part of the FDA's regulations state that if a firm receives complaints on a device malfunction, or a injury, illness, or death associated with a medical device, they must report this incident to the FDA. This report, known as an adverse event report (Form 3500A), is currently submitted manually to the FDA.

The FDA is working on an electronic submission program called "eMDR". This program will enable companies to submit MDRs to the FDA gateway, a secure agency portal for electronic submissions. Working with representatives from the FDA, EtQ has developed a tool that will allow users to electronically submit MDRs to the FDA gateway, seamlessly and efficiently.

Using the EtQ Reliance eMDR Submission Utility, not only are users able to automatically submit their reports directly to the FDA, but it also provides a level of functionality that ensures fewer submission errors, tying the submission process directly into the Complaints Handling and CAPA workflows. ""Using the eMDR Submission Utility, our users are able to automate the FDA submission so it is done faster and with much less chance of errors," says Morgan Palmer, CTO of EtQ. "Data collected by our system is imported directly into the electronic submission form, which is then submitted automatically to the FDA. There is no double-entry of information, and the overall process leads to faster response times to critical events within the system."

The FDA's eMDR Submissions program is currently in the pilot phase, and EtQ is one of the few solution providers in the market participating in this program. EtQ is currently working with several customers on its eMDR Submission Utility, all of whom are planning to use the tool to electronically submit MDRs once the FDA pilot phase is completed.

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