FDAnews Device Daily Bulletin

DEVICE FIRMS' ADVERSE EVENTS REPORTING FOCUS OF HHS'S OIG

Dec. 1, 2005
A A

The HHS's Office of Inspector General (OIG) plans to examine adverse events reporting for medical devices and review the FDA's process for addressing deficiencies in foreign device manufacturing facilities, the OIG said in its fiscal 2006 work plan.

The OIG will determine how and to what extent medical device manufacturers and user facilities comply with mandatory reporting requirements for adverse events associated with medical devices, according to the work plan that outlines multiple probes into programs and activities of HHS's agencies.

The FDA requires medical device manufacturers to report deaths, serious injuries and device malfunctions to FDA within 30 calendar days, or within five working days if the event requires remedial action to prevent substantial harm to the public, the OIG noted. "We will also evaluate how and to what extent FDA uses medical device adverse event reports to identify and address safety concerns," the work plan said.

The OIG's Work Plan, Fiscal Year 2006 is at http://www.oig.hhs.gov/publications/docs/workplan/2006/WorkPlanFY2006.pdf (http://www.oig.hhs.gov/publications/docs/workplan/2006/WorkPlanFY2006.pdf).