GAO Concerned About Medical Device Approval Process

GAO has raised concerns about FDA's review of high-risk medical devices
GAO has raised concerns about FDA's review of high-risk medical devices

The Government Accountability Office (GAO) has raised concerns about the approval process that high-risk medical devices undergo — or rather, don’t undergo — by the U.S. Food and Drug Administration (FDA). The federal watchdog group says the agency recently took steps to see if certain high-risk medical devices, such as artificial hips and external defibrillators, should be tested more rigorously before being sold. But the FDA continues to approve these devices every year without much review, which puts patients receiving these devices at risk.

As staff reporters Jim Spencer and Janet Moore explain in their article in the Minneapolis Star Tribune, “Despite reports of failures and recalls, 26 types of high-risk medical devices could still enter the U.S. market through an approval process that requires no human testing, said Marcia Crosse, the GAO’s director of health care.”

A slew of device recalls, including one by Johnson & Johnson in 2010 of 93,000 artificial hips, has raised questions about the agency’s approval process. The FDA has dragged its feet in implementing a 1976 law that requires all high-risk medical devices to undergo a rigorous review. But if companies can prove the devices are similar to existing ones on the market, many of these high-risk devices are cleared with the bare minimum of tests under the 510(k) program, which is an expedited approval process.

Barry Meier reports in his piece in The New York Times:

At the start of the Obama administration, F.D.A. officials indicated that they would take an aggressive approach to the regulation of medical devices. But in more recent months, they appear to have backed away from that stance.

The F.D.A. has asked the Institute of Medicine to review its device approval process. That group is expected to issue its report later this year.

Source: “GAO adds to concerns about medical device approval process,” Minneapolis Star Tribune, 04/13/11
Source: “Group Faults the F.D.A. on Oversight of Devices,” The New York Times, 04/12/11
Source: “High-Risk Medical Devices Fail to Get Full Review, GAO Says,” San Francisco Chronicle, 04/13/11

Rajendrani "Raj" Mukhopadhyay is a science writer and editor who contributes news stories and feature articles on scientific advances to a variety of magazines. Raj holds Ph.D. in biophysics from Johns Hopkins University.

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