Report Could Tighten FDA's Oversight of Medical Devices

Manufacturers already taking issue with findings, to be released Friday by Institute of Medicine

Amanda Gardner

Amanda Gardner

Updated on July 29, 2011

THURSDAY, July 28, 2011 (HealthDay News) -- The U.S. Institute of Medicine plans to release a report Friday that could change the way medical devices are regulated.

The highly anticipated report was requested by the U.S. Food and Drug Administration back in 2009, and is expected to recommend that medical devices such as artificial joints and pacemakers go through a more rigorous approval process before reaching the market.

Consumer advocacy groups have been critical of FDA oversight of medical devices, arguing that they typically have been cleared too quickly.

"FDA's oversight and review process is too weak and needs to be strengthened," said Dr. Michael Carome, deputy director of Public Citizen's Health Research Group.

What appears to be at issue in the forthcoming Institute of Medicine (IOM) report is the fast-track 510(k) process of device approval, under which most medical devices reach the market.

This process speeds approval of devices if they are "substantially equivalent" to an existing device.

According to published reports, the majority of medical devices, or about 3,000 annually, are ushered in this way.

A minority of higher-risk devices, such as implanted heart defibrillators, have to go through a more rigorous approval process, not unlike that required for new drugs.

Patient-safety advocates say that too many devices are cleared under the 510(k) program, which is too lax to begin with.

"We believe that the process for approving devices under the 510(k) program frequently is deficient because of the application and the loose interpretation of what it means to be "substantially equivalent to a predicate device," Carome said.

But industry groups say the program gets needed devices to patients much quicker, and the medical device industry has launched a campaign in Washington, D.C., to cast doubt on the report even before it is released, The New York Times reported.

In a statement, Mark Leahey, president of the Medical Device Manufacturers Association, said " we remain concerned about efforts to overhaul a regulatory pathway that would create additional uncertainties and slow patient access to medical therapies. Moving forward, we will continue to work with FDA and all stakeholders to ensure a more predictable and reasonable process is in place."

The IOM report follows several widely publicized recalls of devices, including the recall last year of two artificial hip systems that had been implanted in almost 100,000 patients.

Meanwhile, the FDA has issued two warnings in three years about surgical mesh devices, which are used to support prolapsed organs, such as the bladder, MSNBC reported.

More information

Here are details on Friday's Institute of Medicine press briefing.

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