Studies Suggest Flaws in FDA Device Approvals

Posted on January 5, 2010 in Consumer Goods, Health & Medicine, Recent Studies, Technology

The Food and Drug Administration’s approval process for devices like pacemakers and stents may be flawed, according to two independent studies. Researchers found that device studies lacked critical patient information, clear goals and randomization.

A study conducted by researchers from the FDA and Boston’s Beth Israel Deaconess Medical Center found that safety targets weren’t always clearly defined. Researchers at the University of California, San Francisco reported that heart devices receive approval based on research done outside the United States on small groups of patients.

FDA officials contended that University of California researchers only looked at summaries of the device approvals, as opposed to the full research. However, the FDA is still reexamining its device program and making changes. In both studies, researchers looked at pre-market approvals from 2000-2007. They did not examine the safety of the approved devices.