13-April-2011

The U.S. Government Accountability Office told a Senate committee on April 13, 2011, that the Food and Drug Administration must improve its oversight of medical devices needs, including premarket testing of the devices and oversight of recalls and devices already on the market, Law360 reported in its story, "FDA Must Improve Medical Device Oversight, GAO Says."

In a Senate Aging Committee hearing, Marcia Crosse, director of the GAO's health care team, said the oversight of medical devices such as pacemakers and hip implants was placed on the GAO's "high-risk" list in 2009 and remains a concern in 2011, according to the Law360 story.

A GAO preliminary report accompanying the testimony said medical device manufacturers initiated 3,510 voluntary medical device recalls from 2005 to 2009, an average of just over 700 per year.

Crosse also said the FDA should improve its review of medical devices before they hit the market, Law360 reported. The GAO's 2009 report identified 26 types of high-risk medical devices that were passed through a less-stringent review process, and 25 of those devices, including prosthetic hips, had still not been subject to the stricter test intended by Congress, Crosse said.

The FDA does not always require clinical data, even for implantable devices, and since 2009 the FDA had cleared at least 67 examples of the 26 types of devices highlighted by the GAO, according to the report.

The committee heard testimony from others. Ralph Hall, a professor at the University of Minnesota Law School who serves as an advisor with B&D; Consulting, said the FDA was "performing well" in the premarket testing of medical devices. Hall said most recalls were caused by failure in quality control, not a lack of clinical testing, the Law360 story reported.