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IOM listens to worries, suggestions for FDA medical device approval

by Brendon Nafziger, DOTmed News Associate Editor | June 18, 2010
Examining fast track
device approvals
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.