GAO Finds Flaws in FDA Device Approval Process

The Government Accountability Office (GAO) is urging the U.S. Food and Drug Administration (FDA) to use the most stringent pre-market review process in approving high-risk medical devices, according to a GAO report.

The GAO said the HHS’ agency responsible for oversight of medical devices sold in the United States has not completely applied that process to all Class III devices, a class that includes pacemakers and replacement heart valves and implantables that present higher risks to patients. The FDA uses two review processes: the faster and cheaper 510 k process to review less risky Class I and II devices, such as bandages, and the pre-market approval, or PMA process, for higher risk Class III devices.

In 2005, the average FDA cost for performing a 510 k review was $18,200, while the estimate for doing a PMA was $870,000 and in 2009 the application fee for a 510 k submission was $3,693, while a PMA application was $200,725.

In the 64-page report, the GAO said some Class III devices had been approved with less scrutiny, noting that between 2003 and 2007 the FDA used the less stringent 510 k process to review 342 submissions, in spite of the FDA’s own rules and congressional intent for stricter review. The FDA agreed with the GAO report and recommendations to either reclassify the devices or subject them to the PMA approval process.

Read the GAO report (pdf).