On June 13, 2008, the Food and Drug Administration (FDA) published a direct final rule removing a requirement for medical device baseline reports that the agency deems no longer necessary. Currently, device manufacturers provide baseline reports when they submit the first adverse event report for a device model. Because most of the information in these baseline reports is also submitted to FDA in individual adverse event reports, FDA is removing the requirement for baseline reports to streamline reporting requirements. The rule will become effective October 27, 2008, unless a comment is submitted within 75 days raising a significant objection to the change. Therefore, FDA also has published a companion proposed rule to provide a procedural framework to finalize the rule in the event the agency withdraws the final rule in response to adverse comments. The FDA will accept comments on both documents through August 27, 2008.