Dec 30, 2009 8:53 AM by Associated Press

Studies spotlight problems in FDA device approvals

Two new studies find shortfalls in the Food and Drug Administration's approval process for heart devices such as pacemakers and stents.

Researchers from the FDA and Boston's Beth Israel Deaconess Medical Center said studies submitted by device makers didn't clearly spell out safety targets. They add that submissions were missing important information on patients, such as how many had heart disease or diabetes.

The study published in the American Journal of Therapeutics looked at research behind 88 heart and blood vessel devices.

Separately, a report that appears in the Journal of the American Medical Association found many devices were approved based on small studies - 300 patients on average. Of the 78 heart and blood vessel devices researchers reviewed, the report says two-thirds were approved with the results of just one study.

The FDA says it's taking a close look at its device program and making changes.


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