Prominent doctor raises concerns over change in heart devices

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New York Times, December 11, 2008

Federal regulators are about to approve use of a critical new electrical component for implantable heart devices without adequately testing for its potential risks, says Robert G. Hauser, MD, of the Minneapolis Heart Institute in an article published in The New England Journal of Medicine. Hauser argues that manufacturers should perform at least some clinical trials on patients to ensure that the new technology is not prone to short-circuiting. Underlying Hauser's argument is a question that heart device producers, regulators, and lawmakers have been grappling with in recent years: When medical devices the FDA has already approved undergo technical changes, how much and what kind of additional testing should occur before they are allowed to be sold?

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