The OIG has issued a report entitled “Adverse Event Reporting for Medical Devices.” According to the OIG, the FDA’s Center for Devices and Radiological Health (CDRH) does not use adverse event reports in a systematic manner to detect and address safety concerns about medical devices. Specifically, CDRH has not documented follow-up on adverse events, it does not consistently read adverse event reports for the first time in a timely manner, and it rarely acts when manufacturers and user facilities submit reports late. The OIG recommends that FDA develop a clear protocol for reviewing adverse event reports, including: documenting follow-up on adverse events, documenting that CDRH is meeting its own guidelines for reviewing high-priority adverse event reports, following up with manufacturers who routinely submit reports late or with incomplete information, and enhancing outreach strategies to reduce user facility underreporting. The OIG also recommends that FDA seek legislative authority to eliminate the requirement that user facilities submit annual reports. The FDA agreed with the OIG’s recommendations.