(AP) — The government should abandon a 35-year-old system for approving most
medical devices in the U.S. because it offers little to no assurance of safety
for patients, a panel of medical experts concludes in a report Friday.
surprise recommendation from the Institute of Medicine panel calls for a
massive reworking of how the government regulates medical devices, a $350
billion industry that encompasses everything from pacemakers to X-ray scanners
to contact lenses.
group’s advice, commissioned by the Food and Drug Administration, is not
binding. But it could signal a new era of tighter standards for medical device
manufacturers, who have long benefited from less safety scrutiny than their
peers in the drug industry.
requires that most new prescription drugs go through clinical trials to prove
that patients fare better after receiving medication. Most devices only have to
show that they are similar to devices already on the market. Only a handful of
truly new devices must undergo extensive testing to prove they are safe and
highly unusual move, the FDA said Friday that it disagreed with the group’s
recommendations, but would hold a public meeting to discuss them. The FDA has
already been working for more than a year to make the 510(k) process more
predictable and less bureaucratic, efforts that would go to waste if the system
believes that the 510(k) process should not be eliminated but we are open to
additional proposals and approaches,” said FDA’s device director Jeffrey
Shuren, in a statement.
report arrives as the FDA fends off pointed criticism from manufacturers who
say the agency has become too slow and bureaucratic in clearing new devices,
driving up costs for companies and forcing some out of business. Despite the
relative speed of the 510(k) process, they point out that some devices still
get tied up in red tape, ultimately reaching the U.S. market two years after
launching overseas. In the past year, companies have taken their arguments to
Capitol Hill, where lawmakers have grilled FDA officials over device reviews.
device industry’s chief lobbying group immediately dismissed the proposal as
“a disservice to patients and the public health.”
report’s conclusions do not deserve serious consideration from the Congress or
the Administration,” said Stephen Ubl, president of the Advanced Medical
Technology Association. “It 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
Institute of Medicine panelists, mostly doctors and researchers, appear to have
overwhelmingly sided with public safety advocates who have argued for years
that devices used to treat and detect illnesses must undergo real medical
sought the group’s advice as it updates the system used to clear more than 90
percent of devices in the U.S. The so-called 510(k) system was created by
Congress in 1976 to grant speedy approval to devices that are similar to
products already on the market. The pathway was originally intended as a
temporary method to grandfather in devices that had been used for decades.
Instead it has become the standard tool to launch new medical implants.
generally recommends ways to improve or modify government programs, but in an
unexpected move the panel said 510(k) approvals are “flawed” and
should be eliminated completely.
system was put in place 35 years ago that does not really assess safety and
effectiveness,” said panel chair David Challoner, former vice president of
health affairs at University of Florida. “We need something different for
the next 35 years. We’re dealing with a whole new world: new technology, new
materials and new data.”
and the other panelists recommend the FDA develop a new system based on safety
metrics and tracking device failure rates in the real world. He said better
tracking of device complications could take the place of premarket testing,
which would be financially unfeasible if applied to all new devices.
group stresses that medical devices cleared through the pathway are not
inherently unsafe — most probably are safe — but the approval system itself
provides little assurance to doctors and patients.
510(k) system is popular among manufacturers because it is a faster, cheaper
path to market than the review process for first-of-a-kind devices, which must
undergo rigorous medical testing. Hip replacements, CT scanners and drug pumps
are among the devices cleared by 510(k).
generations of devices have been cleared year after year, FDA critics say
dangerous devices that pose real risks to patients have slipped through because
they vaguely resemble products approved decades ago.
there was this idea that the 510k would wither away and over time more and more
new devices would go through the more onerous path. But instead there are more
devices cleared this way than ever,” Dr. Diana Zuckerman, director of the
nonprofit National Research Center for Women & Families, said in an
this month Zuckerman and other safety advocates critics seized on new reports
of painful complications with pelvic surgical mesh as the latest example of the
shortcomings of the abbreviated review system. Reports of pain, bleeding and
infection with the implants are up 500 percent since 2008 among women who’ve
had surgery to support the pelvic wall. The FDA cleared the device for that use
in 2002 via 510(k). Similar safety issues have plagued metal-on-metal hip
implants in recent years.
IOM’s 245-page report will strengthen FDA’s hand against a multimillion-dollar
lobbying effort by medical device manufacturers. But it also poses a host of
challenges for the agency, including how to design and pay for a more
comprehensive medical device system.
4,000 devices are cleared every year under the 510(k) system, while just 50
devices are approved under the more stringent system that requires human
testing. It costs the FDA roughly $800,000 per device when utilizing the more
is a nonpolitical group of experts that advises the federal government on
months, medical device lobbyists and executives have downplayed the legitimacy
of the IOM panel, pointing out that none of them have experience working in the
most panels convened by the agency, the group that drafted Friday’s paper
consists mostly of academics and researchers from institutions like Harvard
University and the National Institutes of Health.
Jeffrey Lerner, who has studied medical technology for over 25 years, said
device makers are still coming to grips with a new regulatory environment that
demands greater safety — often at the expense of profits.
device industry tends to take the position that their industry is competitive
enough already and that anyone wanting to make it tougher is trying to do them
real harm,” said Lerner, who is president of the Emergency Care Research
Institute. “The bottom line is that everybody has got to make adjustments
in an era in which technology is changing and public expectations are