Examining fast track
device approvals

IOM listens to worries, suggestions for FDA medical device approval

June 18, 2010
by Brendon Nafziger, DOTmed News Associate Editor
When it comes to medical device regulation, how do governments strike the right balance between ensuring patients aren't hurt by shoddy products and spurring innovation for new devices?

That was, in essence, the question asked at a public meeting hosted by the Institute of Medicine, an influential research body that met in Washington D.C. for two days of talks this week on the U.S. Food and Drug Administration's so-called fast-track approval process for medical devices.

IOM was tapped by the FDA in September to review a regulatory process that some consider inadequate, a view shared by at least a few of the panelists and members of the public at the meeting Monday and Tuesday at a ballroom in the Hotel Monaco.

While the IOM, which first held a public meeting on the issue two months ago, isn't expected to release its report until March, industry watchers are nervous the institute could call on the FDA to toughen up the 510(k) process, which they fear could hurt the domestic medical device industry, already ailing in a weak economy.

The 510(k) process, born of 1976 legislation, is largely for medium-risk, Class II devices, similar in function to ones already on the market, and covers most imaging and diagnostic tools. In general, it requires the device maker to show the product is basically the same as others already out, and to follow-up with safety surveillance data after it's released. Riskier devices, like pacemakers, get slapped with a Class III label, and have to undergo expensive and lengthy clinical testing before they're allowed on the market.

Although trade groups complain the 510(k) process has slowed recently, resulting in costly approval delays, they believe it's the best tool we have for these types of products.

"AdvaMed believes the 510(k) review process is well designed to assess the safety and effectiveness of low- and moderate-risk medical devices whose risks are well understood from experience with similar devices," Janet Trunzo, executive vice president for technology and regulatory affairs for the Advanced Medical Technology Association, a device lobby, who spoke at the conference, said in prepared remarks.

But during the meeting, some experts worried the whole process resulted in devices getting cleared too fast.

"Our current financial system for startup medical device companies and reimbursement system together conspire to leave us...where things are forced into the market 'quick and dirty,'" said Dr. D. Bruce Burlington, ex-director of the Center for Devices and Radiological Health at the FDA, which oversees the 510(k) process, and now an independent consultant for pharmaceutical companies.

Consumer advocates agreed. "There needs to be a new tone," William Vaughan, of Consumers Union, which runs the magazine Consumer Reports, said. "We have no idea what we're getting when we get one of these [medical devices] in our body. We don't know how long it will last."

But Mark Leahey, head of the Medical Device Manufacturers Association, an industry lobby, observed that the 510(k) process was a "genuine success." Over 100,000 products were cleared by the process since it was instituted over 30 years ago, with few examples of adverse events, he said.

And some doctors groups also liked the status quo.

"The American Academy of Orthopedic Surgeons strongly believes the current 510(k) process combined with surveillance programs provides the most favorable balance between benefits and risks," Dr. Kent Lowry said, speaking on behalf of the group during a public comment period.

But nearly everyone agreed that the situation was difficult, in some ways tougher than regulating pharmaceuticals: The FDA employs nearly 12,000 people, but still lacks the manpower and resources needed to really tackle the hundreds of thousands of products released in the field.

"There are 750,000 different types on the Europe market, compared to no more than 10,000 active molecules in pharma, and probably less than that if you tease down," said Dr. David Jefferys, senior vice president of global regulatory affairs for Eisai Europe Ltd., a pharmaceutical company.

"Once you develop penicillin, it's penicillin," David W. Feigal Jr., an ex-FDA official who now handles regulatory affairs for the drug-maker Amgen, said. "Devices don't just stand still, and I think the development [process] has to fit that as well."

Suggestions on improvements varied, too, with some panelists bemoaning the slow rate of inspection cycles of factories, with the agency sometimes taking years to check up on foreign outfits. But the FDA has been reluctant to accept self-inspections audited by a third-party, as happens in the financial industry, because, as some of the panelists observed, it is, at heart, a law enforcement agency.

"They were not that enthusiastic about third parties and self certification, in part because of their idea they're a law enforcement agency," Feigal said. "You don't see highway patrols self-certifying speed limits. They'd just as soon chase you down themselves."

Nonetheless, as IOM digs down for months of further research -- it's planning a third public meeting on the topic for July -- not all consumers want the group to err too heavily on the side of caution.

"People think that consumer advocates are only concerned about safety," Amy Allina, program and policy director for the National Women's Health Networks, said. "Women also ask, 'Why can't we get a better device?'"

Heather Mayer contributed to this article.