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Capitol Health Call
March 12, 2008

Plant Inspections Lag

JAMA. 2008;299(10):1124. doi:10.1001/jama.299.10.1124-a

A Government Accountability Office (GAO) report shows that the US Food and Drug Administration (FDA) has not met its statutory requirement for inspections every 2 years of US manufacturers of such high-risk medical devices as pacemakers.

In the report, presented at a January 29 hearing before the House Committee on Energy and Commerce's Subcommittee on Oversight and Investigations, the GAO said the FDA estimates that it inspects manufacturers of high-risk devices every 3 years and those producing medium-risk devices (such as hearing aids) every 5 years. And while there is no comparable requirement for inspecting plants outside the United States, the FDA estimated that it inspects foreign manufacturers of high-risk devices every 6 years and those making medium-risk devices every 27 years (http://www.gao.gov/new.items/d08428t.pdf).