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Both studies looked at devices approved from 2000-2007.
Much is at stake with device approval. In 2008, the U.S. Supreme Court found that federal law bars patients from suing manufacturers for injuries caused by FDA-approved devices.
In contrast, consumers can sue drugmakers over FDA-approved drugs. Drugmakers submit rigorous studies when seeking approval of new drugs, generally they must submit large randomized studies.
Redberg said she believes new leaders at the FDA want to improve the approval process. She joined an advisory committee to the FDA on devices last year, after the years covered by the study.
In both new studies, the researchers looked only at so-called premarket approvals. They didn't include devices cleared through an alternative FDA process -- "510(k) submissions" -- used for less risky devices that are substantially similar to approved devices. The FDA has asked the Institute of Medicine to review its 510(k) reviews, following criticism from safety advocates and government watchdogs.
FDA officials said the University of California researchers looked only at summaries of device approvals, rather than the full research. The FDA said the researchers also made faulty assumptions about device research, which is inherently different from drug research.
The most rigorous research randomly assigns patients to get either the experimental treatment or a standard treatment, or sometimes a placebo. Patients and sometimes doctors are "blinded," meaning they don't know which patients receive the experimental treatment.
FDA officials said requiring randomized studies for second and third generation devices would delay bringing engineering refinements to the market. They said it's often impossible to conduct blinded studies with devices.
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