Studies find FDA medical-device approval flawed

Two new studies find shortfalls in the Food and Drug Administration’s approval process for heart devices such as pacemakers and stents. Safety targets often weren’t clearly spelled out in the research submitted by devicemakers and important patient information was missing, according to one study. A separate analysis found heart devices frequently got the FDA’s blessing based on research done outside the United States. Many device studies lacked standards most scientists expect: randomization and a clear goal. The FDA is taking a close look at its device program and wants manufacturers to adhere to tougher research guidelines that will be out in 2010.

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