* Advisers recommend replacing 510(k) approval program
* Say program not adequate to protect patients
* FDA disagrees, will not eliminate accelerated approval
* No dramatic changes seen in near term
(Adds further IOM comments, analyst reaction)
By Andrew Seaman
WASHINGTON (Reuters) - An advisory group said the
U.S. fast-track approval process for medical devices is fatally
flawed and should be replaced, but the Food and Drug
Administration said the recommendation was a non-starter.
The FDA had asked for the Institute of Medicine report as
part of a broad agency review of its device unit, an area
dogged by high staff turnover, funding woes and major recalls
in recent years of devices ranging from artificial hips to
The IOM found the fast-track approval process, called
510(k), does not adequately protect patients and recommended a
more thorough process that would likely to raise the costs for
device makers with pre-market and post-market device reviews.
"What we are recommending is that the 510(k) is fatally
flawed in terms of it not evaluating safety and effectiveness
of a device," said Dr. David Challoner, chairman of the IOM's
But the finding was swiftly rejected by the FDA's top
"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," Dr. Jeffrey Shuren, director of the FDA's Center for
Devices and Radiological Health, said in a statement.
Wall Street analysts said the report was not a
game-changer, at least in the near term. Legislation would be
required for any significant changes to the device approval
"The 510(k) process was established in 1976 and it was
meant to be a temporary stop-gap," said Thomas Gunderson, an
analyst with Piper Jaffray. "The process can certainly be
improved upon, but at the current pace, I don't see this (IOM
report) having any meaningful impact."
Senator Al Franken said the IOM was advocating new burdens
for the medical device industry without a clear path to a more
"Calling for the elimination of the 510(k) process could be
very harmful to innovation," said Franken, a member of the
Senate's health committee and whose state of Minnesota is home
to Medtronic Inc, a major device maker.
The 510(k) program allows medical devices to get to market
faster if they are "substantially equivalent" to an existing
Critics say the accelerated 510(k) process is too widely
used and leads to inadequate testing for some risky devices,
but it is defended by the industry as necessary to speed
technologies to patients.
The medical device industry has argued for either leaving
the 510(k) process as it is or further streamlining the
approval process. Most new medical devices -- about 4,000 in
2009 -- are cleared through the accelerated program.
IOM's Challoner said in a briefing on Friday that he
recognizes the report is suggesting "a paradigm shift" that
could be disquieting to the medical device industry, consumers
Another IOM committee member, however, said the current
510(k) system "has been reasonably safe."
"We do not believe that one has to shut down the system
tonight. We think it is working adequately in the short term,"
said William Vodra.
The industry group Advanced Medical Technology Association,
or AdvaMed, said Congress and the FDA should not seriously
consider the report's conclusions.
"(The report) proposes abandoning efforts to address the
serious problems with the administration of the current program
by replacing it at some unknown date with an untried, unproven
and unspecified new legal structure," AdvaMed's CEO and
president Stephen Ubl said. "This would be a disservice to
patients and the public health."
Medical devices range from simple bandages to complex
implants such as pacemakers, stents and artificial knees. Other
than Johnson & Johnson, the largest medical-device
makers include Medtronic, Boston Scientific Corp and
Abbott Laboratories Inc.
High-profile incidents include a massive recall last year
of artificial hips by Johnson & Johnson's DePuy unit.
Some 93,000 patients worldwide had that line of hip
Automated external defibrillators, used in public places
such as airports to revive cardiac arrest victims, have also
made up a significant portion of 510(k) recalls in recent
years. Health officials are looking at thousands of reports of
malfunctions which may have led to patient harm or death.
(Reporting by Andrew Seaman; Additional reporting by Alina
Selyukh and Debra Sherman; Editing by Tim Dobbyn)
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