The researchers found that 21 out of the 113 devices were approved through the PMA process, while 80 were cleared using the 510(k) process (8 devices were exempt from any sort of FDA regulation).

In the study, the authors reasoned that the FDA has relied on the 510(k) process more than PMA because it's considerably cheaper for the CDRH to review thousands of devices on an annual basis using the less stringent approval procedure. In 2005, it cost the FDA an average of $18,200 to review a 510(k) submission, while a review of a PMA submission cost the agency $870,000, according to the study.

"The Congress has not appropriated sufficient funds to the CDRH to use the more expensive PMA process for most devices, and this large cost differential creates an incentive for CDRH to rely heavily on the 510(k) process," the authors wrote. "The FDA is partially supported by industry user fees, but the FDA charges much smaller user fees to review medical devices than it charges to review prescription drugs, even for the largest companies."

One of the study's authors, Dr. Steven E. Nissen, served as a panelist at the hearing. Nissen is the chairman of the department of cardiovascular medicine with the Cleveland Clinic. In his testimony, Nissen said the study's finding that 71 percent of the high-risk recalls involved devices cleared using the 510(k) process, "represents a paradox."

"Federal regulations require devices used to support or sustain life to undergo a full PMA approval process," he said. "By law, these life-sustaining devices should not be cleared using the 510(k) provision. Yet, 71 percent of recalls for defects that could 'cause serious health problems or death' were originally approved using the 510(k) pathway."

Ralph F. Hall, a professor and practitioner of law with the University of Minnesota Law School and CEO of MR3 Medical LLC, a medical device startup working on cardiac rhythm devices, also examined the FDA approval process in the same study period. However, he ended up with different results.

He examined the overall safety profile of medical devices approved or cleared by the FDA from 2005 to 2009 by using Class I safety recall data.

Hall found that more than 99.5 percent of the 510(k) medical submissions assessed during the study didn't result in a Class I safety recall. Hall also found than less than 9 percent of the Class I recalls involved potential undiscovered clinical risks. "As such, increased pre-approval clinical testing would not have any meaningful impact on reducing the number of Class I recalls," he said in his testimony.

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