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FDA device center's adverse event assessments get OIG critique

This article was originally published in The Gray Sheet

Executive Summary

The FDA device center does not systematically use adverse events to detect and address device safety concerns, according to an Oct. 23 report from the Health and Human Services Office of Inspector General. From an investigation of the center's adverse event databases and interviews with officials, OIG concludes that CDRH does not consistently document follow-up on adverse event reports, and staffers do not consistently read the reports in a timely manner after submission. The agency also does not decisively enforce reporting deadlines, in particular the five-day deadline for events that require action other than routine maintenance or service to prevent a public health issue. OIG recommends that FDA develop a better protocol for reviewing adverse events and enhance outreach to user facilities to prevent underreporting. FDA says it agrees with the recommendations
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