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April 9, 2009

F.D.A. to Check Safety of Old Devices

By GARDINER HARRIS

WASHINGTON — Federal regulators said Wednesday that that they

would ask makers of some of the riskiest medical devices to prove that
their products were safe and effective — a step that critics have said was
long overdue.

In January, the Government Accountability Office issued a report

scolding the Food and Drug Administration for failing for decades to fix
its system for reviewing categories of devices that have been on the
market since before the enactment of the medical device law in 1976.
Such legacy devices, as they are known, were originally allowed on the
market with minimal testing. But in the 1976 law Congress told the
F.D.A. to gradually reclassify these older devices and decide which ones
needed extensive testing before approval of new versions and which
ones did not.
The agency never finished that process, leaving 27 different types of
devices unexamined — products that include artificial lung membranes,
external defibrillators and various pacemaker components.
For decades, the F.D.A. has approved devices in these categories for sale
without demanding rigorous tests showing that they work safely.
Investigators for the accountability office stated that “it is imperative
that F.D.A. take immediate steps” to fix its system for approving such
devices, and the agency agreed.

The agency has already undertaken a review of two of these older device
types, and it announced Wednesday that it was requiring makers of the
other 25 types of devices to submit information to the agency within

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120 days, detailing the products’ safety and effectiveness.

Mary Long, an F.D.A. spokeswoman, said she could not predict how
long the reclassification process for the older devices would take.
“We have to review each device type separately,” she said. “It will take
some time.”
Industry groups predict that the F.D.A. will conclude that most of the
products are not risky enough to warrant greater scrutiny. “The device
types subject to the F.D.A. notice have already been thoroughly
reviewed by the agency,” said Janet Trunzo, executive vice president of
the Advanced Medical Technology Association.
But consumer advocates argue that the agency’s entire process for
approving medical devices needs overhauling.
“It’s great that F.D.A. is finally going to look at pre-1976 devices, but the
bigger problem is the low standards for approving any and all devices
without clinical trials or any proof of safety or effectiveness,” said Diana
Zuckerman, president of the National Research Center for Women and
Families.

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