FDA Proposes Electronic Reporting

The U.S. Food and Drug Administration (FDA) has proposed that three of its centers, including the Center for Devices and Radiological Health (CDRH), require manufacturers to submit reports electronically.

The rules—one that applies to electronic medical device adverse event reporting and one that applies to electronic drug and biologic product adverse experience reporting—would mandate incidents be reported in an electronic format that the FDA can process, review and archive.

“Both proposed rules will improve the agency’s ability to obtain safety information more quickly, which will help lead to faster identification of potential safety problems,” said David Buckles, Ph.D., director of the Division of Postmarket Surveillance at the CDRH. “Information obtained from these reports may be critical to future action that improves patient safety.”

Currently, CDRH receives most mandatory medical device adverse event reports on paper, which requires that reports are manually entered into the center’s adverse event database, called the Manufacturer and User Facility Device Experience (MAUDE) database, for further analysis.

The electronic medical device reporting system, known as eMDR, provides a choice of two electronic options for reporting postmarket safety information: eSub, which runs on free software available from the FDA, or, for large manufacturers, which can submit hundreds of reports per year, a batch submission protocol, based on a widely recognized informatics standard.