Apr 18, 2011

In April 13 testimony before the US Senate’s Special Committee on Aging, Government Accountability Office (GAO) health care division director Mary Crosse raised substantial doubts about the Food and Drug Administration’s (FDA) oversight of medical devices.

Crosse’s testimony was based on evaluations of steps the FDA has taken since a set of  recommendations issued by the GAO in early 2009 to improve the regulator’s premarket review process; the GAO had expressed particular concern regarding the FDA’s practice of clearing some Class III devices through the 510(k) process. Acknowledging that the agency has rolled out strategic goals to phase out this practice, Crosse noted that 26 Class III device types can still gain clearance for sale in the US via 510(k) rather than premarket approval (PMA).

 “Since we issued our report in January 2009, FDA cleared at least 67 individual submissions that fall within 12 of these Class III device types through the 510(k) process,” Crosse said in prepared statements.

The FDA’s handling of recalls also garnered poor reviews from the GAO director.

“Our preliminary findings suggest that shortcomings in FDA’s oversight of the medical device recall process may limit the agency’s ability to ensure that the highest-risk recalls are being implemented inan effective and timely manner,” Crosse stated. “These shortcomings span the entire range of the agency’s oversight activities—from the lack of a broad-based program to systematically assess trends in recalls, to inconsistencies in the way FDA ensures the effective completion of individual recalls.”

Crosse went on to cite alarming examples of high-risk devices slipping through the cracks of the FDA’s recall process.

While the FDA has come under fire from all sides in recent months, this new GAO critique does not fit neatly alongside arguments from the medical device industry that the agency’s review process has become too onerous, and that a revised 510(k) process would impede efficient introduction of cutting-edge devices into the US market. Both the GAO and industry arguments emphasize more consistency in how the FDA applies and enforces its regulations, but the evidence supplied by Crosse points in the direction of more robust review and post-market surveillance systems, while industry groups continue to push for efficiency and speed to market. 


  • Stewart Eisenhart