FDA to go digital for post-market safety reporting

From HealthImaging: FDA to go digital for post-market safety reporting:

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.

Excellent. The more the FDA pushes for digital reporting, the more impetus that will give digital pathology.