After a series of press reports about internal scientific disagreements at the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) regarding certain medical device approvals, in October 2009 CDRH issued new policies and procedures for resolving internal scientific disagreements related to regulatory decisions. The OIG recently released a report, “Scientific Disagreements Regarding Medical Device Regulatory Decisions,” examining the nature of 36 identified scientific disagreements that occurred during FYs 2008 through 2010. The purpose of the review was to describe the extent and nature of identified scientific agreements; to determine whether CDRH follows its policies for resolution; and the extent to which CDRH’s new policies have been implemented. As part of this review, OIG evaluated the effectiveness of the new policies and procedures in addressing three disagreements that occurred after October 2009. Among other things, the OIG found that while administrative files related to scientific disagreements contained required documentation, accountability for file completeness is unclear. In addition, not all CDRH managers and reviewers have received training on the new procedures for internal dispute resolution. More broadly, the OIG identified challenges for CDRH “in identifying and resolving scientific disagreements because of uncertainty about regulatory definitions and processes and staff perceptions about expressing differences of opinion.” To address these issues, the OIG recommends that FDA more clearly define documentation and resolution requirements; implement mandatory training and tracking of training; and assign accountability for administrative file contents completion. The FDA concurred with the recommendations.