The FDA is working on an electronic submission program called eMDR, which will let companies submit MDRs (medical device records) to the Agency. Working with FDA representatives, software developer EtQ Inc., Farmingdale, NY (EtQ.com) developed a program that lets users do just that.

The company says its EtQ Reliance, software for identifing, mitigating, and preventing high-risk events, lets companies share information on their medical devices with the FDA, and comply with applicable quality standards.

The FDA insists that companies tell them when firms receive complaints on devices that malfunction or cause injury, illness, or death. This adverse-event report (Form 3500A), is usually submitted to the FDA on paper.

EtQ says eMDR submission ensures fewer errors. It ties submissions directly into the Complaints Handling and CAPA workflows. “The eMDR submission also lets users complete submissions faster,” says EtQ CTO Morgan Palmer. “Collected data goes directly into an electronic submission form, which is submitted to the FDA. There is no double-entry of information.” The FDA's eMDR Submissions program is in the pilot phase.