FRIDAY, July 29 (HealthDay News) -- 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
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
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
"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."
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