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Andrew Seaman
July 30, 2011

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 year of devices rang­ing from arti­ficial hips to heart defib­rillators.

The IOM found the fast-track approval process, called 510(k), does not adequately pro­tect pa­tients and rec­ommended a more thor­ough approval process 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 committee.

But the find­ing was swiftly rejected by the FDA’s top device of­ficial.

“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.

The 510(k) program al­lows med­ical devices to get to mar­ket faster if they are “sub­stantially equiva­lent” to an exis­t­ing prod­uct.

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.

The FDA has proposed changes, including the pos­sibility of cre­ating a new cat­egory of more risky devices that would require more data to win approval.

But the IOM committee said the FDA should not waste its lim­ited resources on chang­ing the current program. In­stead, the committee said the FDA should focus on devel­op­ing a new framework.

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 im­plant.

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.

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 Inc, Boston Sci­entif­ic Corp and Abbott Lab­orato­ries Inc.

The IOM suggested the FDA start col­lecting information to build the new process, including post-mar­ket data for devices. Congress should then en­act leg­is­lation to design the reg­ulatory framework, accord­ing to the report.

“A new system needs to be put in place that will be more ef­fective especially in post-mar­ket surveillance,” said Challoner.

(Reporting by Andrew Seaman; Additional reporting by Alina Selyukh; Editing by Tim Dobbyn)

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