The FDA is proposing to amend post-market safety reporting regulations for three of its centers to require that manufacturers and other facilities subject to current reporting requirements submit their reports in an electronic format.
The agency issued two proposed rules: one that applies to electronic medical device adverse event reporting and one that applies to electronic drug and biologic product adverse experience reporting.
Additionally, the agency stressed that this proposed change would not alter what types of incidents are required to be reported to the FDA—it would require that the incidents be reported in an electronic format that the FDA can process, review and archive.
Currently, Center for Devices and Radiological Health (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.
“Not only is this step costly, but it hinders CDRH’s ability to review safety data quickly to uncover potential public health problems,” the FDA stated.
The proposed regulation for medical devices would require manufacturers, importers and user facilities to submit reports to the FDA in electronic format, which will be loaded into the MAUDE database.