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Study Questions FDA Approvals of Cardiac Devices
Date:12/29/2009

ire consideration of unique design considerations," the agency said in its statement. For example, the finding that 65 percent of pre-market approvals came after just one study was cited in by the researchers as a weakness in FDA procedure. "However, in many cases, the mechanism of action of devices, physical and local, is understood and predictable... As a result, a single pivotal device study may be all that is needed to demonstrate safety and effectiveness," the FDA statement said.

The agency also noted that the randomized, controlled trials used for drug testing are often not appropriate when testing devices. Patients cannot ethically be "blinded" to whether they are receiving a stent, bypass or a drug for a heart problem, for example. And trials on a very large scale are also improbable for expensive and experimental devices such as heart valve implants, the FDA noted. "These examples demonstrate that device clinical trials often must incorporate practical realities that are not present with standard drug development," the agency said.

The study did not specifically address whether or not the current approval process has led to actual harm in patients, although Redberg said this is a question "we may address in future work."

But for now, she said, "I think clear requirements from the FDA on the strength of data required for device approval, in terms of type of study, type of endpoint, length of follow-up, completeness of data and design of study would help, as well as post-marketing data requirements."

"We are clearly entering a period of time during which there is going to be increased scrutiny about what we do," Garratt added. "I welcome that, but am concerned that the scrutiny might be misdirected. The implication from the paper is that the FDA is being too shoddy and sloppy in its approval process, allowing too many devices to get approved and it's running up the health-care bill. I don't think that's fair. We've see
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