In her testimony, Redberg, director of women's cardiovascular services, division of cardiology, with the UCSF Medical Center and editor of Archives of Internal Medicine, argued that the 510(k) process, conceived in 1976, is too outdated to handle today's complex technologies, especially in the fields of cardiology and orthopedics. "In contrast to most devices in the 70s, the newer products pose substantially greater risks -- even life-threatening risks -- to patients," she said.

Redberg said that Congress has mandated that high-risk devices go through the more stringent PMA process (or be reclassified as lower-risk products), but according to a 2009 report by the General Accountability Office, the FDA has failed to do so.

Among her recommended improvements to the device approval process, Redberg suggested that high-risk devices cleared through the 510(k) pathway should be supported by significant clinical data. A 2009 study by Redberg and colleagues found that only 27 percent of all premarket approvals were based on a randomized trial and only 14 percent of these trials were blinded.

And after the device is approved, there should be a system of "post-marketing surveillance that would detect serious adverse events in a timely fashion," she said.

"I appreciate greatly the value of innovation in helping me to take excellent care of my patients," Redberg said. "But it is not in the interest of my patients, or the American public, to allow medical devices to get to market without the benefit of high quality clinical studies to demonstrate that they will actually help patients to feel better and even live longer, without causing harm."

Throughout the hearing, Shuren acknowledged that the 510(k) process needs to be improved and emphasized the need for additional funding and resources for the agency to function properly. In response to criticisms that the agency takes too long to approve a device, Shuren said the industry hasn't been pulling its weight -- companies often submit poor clinical data and ignore FDA's recommendations throughout the review process.

When it comes to comparing U.S. and EU's device approval processes, Hall told DOTmed News he agreed with Shuren. The two systems are difficult to compare, but that doesn't mean it shouldn't be done. He said he's working with the FDA on finding potential ways to design a study that will resolve the methodological difficulties.

Click here to read an exclusive report on FDA's search for balance between safety and innovation.

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