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Report Urges New Review System for Medical Devices
Date:7/30/2011

By Amanda Gardner
HealthDay Reporter

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 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
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