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Study of medical device rules is attacked, unseen

By The New York Times  
   July 28, 2011

Allies of the medical device industry are waging an extraordinary campaign in Washington to discredit a coming report by one of the country's pre-eminent scientific groups that examines possible new regulations on the industry. The scientific group, the Institute of Medicine, is scheduled to release a report on Friday that could propose a tougher approval process for a wide range of devices like hip implants, hospital pumps and external heart defibrillators. The report, commissioned by the Food and Drug Administration, comes after several well-publicized recalls in recent years of devices that have failed in thousands of patients, causing numerous injuries. But a business group and others have taken the highly unusual step of making a pre-emptive strike, arguing that the report is biased. That attack began even before the study panel finished its review, and has intensified in recent weeks.

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