Report could tighten the FDA oversight of medical devices.

By Amanda Gardner
HealthDay reporter

Thursday, July 28 HealthDay News)-the US Institute of medicine plans to release a report Friday that could change the way, the medical devices are regulated.

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The report anticipated U.S. food and drug was requested by the Administration 2009 and is expected to recommend that a rigorous approval process through medical products such as artificial joints and pacemakers, before go to the market.

Consumer interest groups were critical FDA oversight of medical devices, argued that they were usually too quickly deleted.

"FDA oversight and review process is too weak and must be strengthened," said Dr. Michael Carome, Deputy Director of public citizen health research group.

What to at issue in the upcoming Institute of Medicine (IOM) report to be, it seems, is the accelerated 510(k)-Prozess of device approval, under which come the medical devices on the market.

This process accelerated approval of devices when they are "substantially equivalent" to an existing device.

Published reports suggest that the majority of the medical equipment or about 3,000 are annually, led in this way.

A minority of higher risk devices, such as heart implanted defibrillators, have to go through a stringent approval process not unlike the new drug required.

Patient safety advocates say that too many appliances under the 510(k) program, the system deletes is from the outset too lax.

"We believe that the process for the approval of devices in the programme 510(k) frequently inadequate, due to the application and the loose interpretation of what it means is"device much be same to a predicate", said Carome."

But industry groups say that the program calls the required devices for patients much faster and brings a campaign in Washington, D.C., to doubts about the report, before it's released, the New York Times reported.

The IOM report follows several recalls of devices, including the recall last year of two artificial hip systems, which was been planted nearly 100,000 patients commonly known.

In the meantime, the FDA reported two warnings to surgical mesh devices in three years, issued support MSNBC has the view bodies, such as the bubble.

Copyright © 2011 HealthDay. All rights reserved.

Sources: Michael Carome, m.d., Deputy Director, health research group, public citizen, Washington, D.C.; The New York Times; MSNBC

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