Follow-Up Review On Internal Control Weaknesses in the Food and Drug Administration's Medical Device 510(k) Review Process

EXECUTIVE SUMMARY:

This final follow-up audit report discloses that the Food and Drug Administration (FDA) had fully or partially taken steps to address the 10 recommendations included in our prior report. Among other things the FDA had established a written "first-in, first-reviewed" sequencing policy, analyzed the propriety of its policy to expedite certain 510(k) submissions, and monitored corrective actions. However, we found more needs to be accomplished in those partially implemented areas in order to more fully address the internal control weaknesses we initially disclosed. We are making recommendations in this report, which, if implemented, should help strengthen the internal controls of the 510(k) process.