CR Industry News: FDA proposes mandatory e-safety reporting rules

FDA proposes mandatory e-safety reporting rules

Rules strengthen data collection

The U.S. Food and Drug Administration (FDA) has proposed to amend postmarket safety reporting regulations to require that manufacturers and other facilities subject to current reporting requirements submit reports in an electronic format, according to an FDA news bulletin.

The proposed rules apply to electronic medical device adverse event (AE) reporting and electronic drug and biologic product adverse experience reporting. The rules only change the way incidents are reported, but do not change what sites are required to report.

Most mandatory medical device AE reporting to the FDA's Center for Devices and Radiological Health (CDRH) have been in paper format, which requires manual entry into the center's AE database, which is called the Manufacturer and User Facility Device Experience (MAUDE) database. The extra step of data entry hinders CDRH's ability to review safety data quickly to uncover potential public health problems, and it's costly, FDA officials say.