FDAnews Device Daily Bulletin

CDRH DROP IN WARNING LETTERS CITED AS LAWMAKERS BLAST FDA

July 13, 2006
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The FDA center responsible for monitoring devices and diagnostics may be slacking on enforcing agency regulations, a House lawmaker contends.

"Despite growing reports of malfunctions in medical devices such as pacemakers and defibrillators," the number of warning letters issued by the Center for Devices and Radiological Health (CDRH) for violations of manufacturing, reporting and quality regulations fell by 66 percent between 2000 and 2005, said Rep. Henry Waxman (D-Calif.) in a recent report.

"The decline in enforcement does not appear to be the result of increased compliance by manufacturers," as the number of violations observed by FDA field inspectors "has remained fairly constant," the document states.

No Follow-Up in One Case

Waxman released the 15-month study, "Prescription for Harm: The Decline in FDA Enforcement Activity," June 26 under the auspices of the House Committee on Government Reform. In the document, he criticizes the agency for lax enforcement practices.

As an example of CDRH's failure to enforce regulations, the report cites a case from the FDA's own internal records in which Ohio firm BOC Gases in 2000 "sold a tank of nitrogen gas as medical oxygen, causing the death of four nursing home residents and injuring six others." ()a href="http://www.fdanews.com/ddl/33_27/" target=_blank>