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Does the FDA's system for approving medical devices work?

That was one of the question the Wall Street Journal posed to three experts, including a former FDA deputy commissioner.


Three health care experts, including a former FDA deputy commissioner, recently sat down with the Wall Street Journal, to discuss whether or not the FDA needs to reevaluate their regulations when it comes to medical devices.

Although they all agree the FDA's job in this area is difficult, some of the them had more polarizing views about the subject than others. Including Scott Gottlieb, former FDA deputy commissioner and a resident fellow at the American Enterprise Institute, who slammed his former employer on a number of issues, including how they approve devices.

"It’s trying to apply a much more uniform and druglike approach to its regulation of medical devices, increasing the hurdles that new products must clear," he told the WSJ. "At the same time, the FDA is treating more low-risk devices like they were high risk."

Also involved in the discussion were Rita Redberg, cardiology professor at UC San Francisco and Bradley Merrill Thompson, device attorney in Washington, D.C. with Epstein, Becker & Green.

Redberg, who pointed out that she sees first-hand the impact of medical devices, was also critical of the agency.

" Only a few percent of all medical devices enter the market via a pathway that requires at least some clinical data," she said. "Simply put, for the vast majority of medical devices, there is NO requirement to demonstrate safety and effectiveness."

Thompson was much more middle of the road, when it came to most issues, including questions about clinical trials and reform.

"Instead of sweeping, fundamental reform to either clamp down or loosen up FDA oversight, I favor continuous improvement guided by continuous review of agency performance data as well as marketplace and scientific trends," he said.

Read the full discussion on the Wall Street Journal's website.

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