Report Urges New Review System for Medical Devices

FRIDAY July 29, 2011 -- The U.S. Food and Drug Administration should scrap the system it uses to approve and regulate "moderate-risk" medical devices such as artificial joints and heart pacemakers, according to a highly anticipated federal report released Friday.

Instead, the FDA should come up with a legally sound process that ensures the devices go through more rigorous review before reaching the market place, according to the report by the U.S. Institute of Medicine (IOM).

At issue is the so-called fast-track 510(k) process of device approval, under which an estimated 90 percent of medical devices -- 3,000 -- reach the market each year. The process, approved by Congress in 1976, was created to approve medical devices if they are "substantially equivalent" to an existing device. While the system was originally designed as a temporary measure to "grandfather" devices already on the market, it has become the primary method for approving moderate-risk medical devices and implants.

The 510(k) system "does not determine a device to be safe or effective," according to the IOM report, which was commissioned by the FDA and is not binding. The IOM is a non-partisan group of scientific and medical experts that is part of the National Academy of Sciences.

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

The 510(k) approval process for medical devices is far more lax than the system used to approve new drugs, which must undergo extensive review in clinical trials before they are approved, and then "post-marketing" surveillance.

"It's not clear that the 510(k) process is serving the needs of either industry or patients, and simply modifying it again will not help," IOM committee chair Dr. David Challoner, emeritus vice president for health affairs at the University of Florida, Gainesville, said in a National Academy of Sciences news release.

"The 510(k) process cannot achieve its stated goals -- to promote innovation and make safe, effective devices available to patients in a timely manner -- because they are fundamentally at odds with the statutes that govern how FDA must implement the process. While current information is not adequate to immediately start designing a new framework, we believe the agency can get the necessary data and establish a new process within a reasonable time frame," Calloner said.

Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement released Friday: "FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs."

The FDA said it would begin accepting public comments on Friday's report.

"Medical devices in the U.S. have a strong track record of safety and effectiveness. The 510(k) program has helped support a robust medical device industry in the U.S. and has helped bring lower-risk devices to market for the patients who need them," Shuren said.

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.

Consumer advocacy groups have been critical of FDA oversight of medical devices for years, arguing that they typically have been cleared too quickly and aren't always safe.

"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.

"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 510 (k) program gets needed devices to patients much quicker.

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."

More information

To learn more visit this FDA website.

Posted: July 2011


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