FDA’s Shuren Tells Industry Medical Device Reviews are Faster, More Efficient

Jane Akre
June 14, 2012

Dr. Jeffrey Shuren, CDRH

If you ask the public, most say they want safer medical devices, not more of them. If you ask the patients profiled in Mesh Device News Desk (MDND) they’d say they wished they’d known that the medical devices they received had come with a prominent warning that would have told them what they were in for.

What industry wants is another story.

Jeff Shuren, who heads the medical device unit of the Food and Drug Administration (FDA) told a life sciences industry group Monday, June 11, that medical device reviews are becoming faster and more efficient and less politically motivated, reports Mass Device.

"Our vision, what we should be trying to do, is to ensure that patients in the U.S. have access to high-quality, safe and effective devices of public health importance, first in the world," Shuren said. "The good news is we're seeing the canary in the coal mine is actually singing these days," Shuren said. "As we start to then implement more of the things we have under way and have additional dollars under [MDUFMA], I think we're heading in the right direction."

Shuren, who heads the Center for Devices and Radiological Health (CDRH), said the agency is seeing fewer device approval applications being rejected and the approval time shortened.

Lawmakers hammered Mr. Shuren last February over the time the FDA takes to review a new medical device. Members of the House Committee on Energy and Commerce criticized the agency as dragging its heels on device approval with many on the committee advocating on behalf of the interests of the medical device industries. (See background story here).

Both the House and the Senate have signed off on the Medical Device User Fee & Modernization Act, (MDUFA) which budgets the FDA for medical device reviews by charging industry a user fee. The $595 million for the next five years represents a doubling of the last budget. The House and Senate must reconcile their versions of MDUFA before sending it onto President Obama for his signature.

However, the House voted version failed to approve legislation that would protect Americans from defective medical devices such as surgical mesh, metal-on-metal hips and defibrillator leads.

In February, Rep. Edward Markey introduced H.R. 3847 the Safety Of Untested and New Devices, Sound Devices Act that would have given the FDA the authority to put the brakes on the approval of a medical device that names as its “substantial equivalent” an earlier device that’s been found to be defective or has been recalled. The authority was also championed by Consumers Union and its Safe Patient Project.

In a poll, Consumers Union asked consumers if safe medical device approvals were at the top of their list.

The poll revealed:

  • 82% of Americans believe that preventing safety problems is more important than limiting safety testing in order to prevent delays and encourage innovation.
  • 91% of poll respondents said each implant should be safety tested before being sold even when similar implants were in use.
  • 71% said that a new device should not be allowed to be sold based on its similarity to an existing implant that has a safety problem or has been recalled.
  • 95% said that effective consumer protections for medical implants should include a nationwide system for tracking medical implants so patients can be notified about safety problems or recalls. No such system currently exists in the U.S. even though it was required by Congress’ previous reauthorization of the law.
  • 66% indicated a high level of concern about safety decisions or recommendations made by expert committees that included doctors who had current financial relationships with medical device makers.

Learn More:

Consumers Union – Safe Patient Project Poll


MDND – May 14, 2012, FDA Closer to Funding Goals - Where is Patient Safety?


MDND, Feb 22, 2012 – Observations on How Lawmakers View Medical Device Regulation


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