FDA found lax in regulating medical devices

A congressional hearing focuses on the approval process and postmarket surveillance amid a push to strip device makers of federal lawsuit preemption.

By Kevin B. O’Reilly — Posted July 7, 2009

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The Food and Drug Administration is falling short in how stringently it evaluates medical devices before they are approved and how well it detects problems with the products once they hit the market, according to a Government Accountability Office report issued in June.

"These shortcomings ... raise serious concerns about FDA's regulation of medical devices," concluded the GAO report (link).

The report, delivered as testimony at a June 18 House Energy and Commerce Subcommittee on Health hearing, could add momentum to a House bill that would allow patients to sue in federal court over injuries allegedly caused by faulty medical devices. The Medical Device Safety Act was introduced in March by Health Subcommittee Chair Frank Pallone Jr. (D, N.J.), and has so far drawn 93 co-sponsors. Pallone held a hearing in May on the bill, which has not yet moved out of his committee.

The GAO report said that from 2003 to 2007, one-quarter of class III medical devices -- those that pose the most risk to patients -- were cleared for market through the less-stringent, less-expensive 510(k) process, in which device makers must show only that the device is "substantially equivalent" to a product already on the market.

The Advanced Medical Technology Assn., a trade group for device makers known as AdvaMed, said the FDA puts devices through a grueling evaluation. "The FDA has a very rigorous, science-based review of class III products ... and is considered the gold standard around the world," said Janet Trunzo, AdvaMed's executive vice president for technology and regulatory affairs.

Postmarket problems

The FDA said in 2006 that the volume of postmarket adverse-event reports submitted exceeds the agency's ability to "consistently enter or review the reports in a routine manner," according to the GAO report. FDA officials told the GAO last year that while they are prioritizing which reports to scrutinize, "they still cannot review all the reports they receive."

The FDA is "not doing well" on the postmarket side, said GAO Health Care Director Marcia Crosse in an interview. "The least burdensome approach to regulation relies on [postmarket surveillance], which is that it says, 'We will require the minimum amount of information up front, because we will watch it very closely on the back end.' But they're not doing that."

The FDA did not respond to American Medical News requests for an interview. In April, the agency required device makers to submit safety and effectiveness information on class III devices to determine if they ought to be reclassified or tested again.

Bruce Wilkoff, MD, vice president of the Heart Rhythm Society, a professional group representing cardiologists and electrophysiologists, said the FDA has been working closely with physicians to help spot heart device problems that may not show up during the approval process.

"The FDA's been trying to do what's best, given the limited funds they have," Dr. Wilkoff said. "They have put more focus on improving the postmarket surveillance part of this."

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