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Study of medical device rules is attacked, unseen

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.