On April 13, 2011, the United States Government Accountability Office (GAO) testified before the Senate Special Committee on Aging regarding FDA’s regulation of high-risk medical devices.

GAO’s concern regarding the regulation of such devices, which GAO notes “include those which are implantable or life sustaining,” dates back to January of 2009, when the agency recommended that FDA “expeditiously take steps to issue regulations for the device types classified as high risk that are currently allowed to enter the market via the 510(k) process.” The high-risk devices the GAO provided as examples were automated external defibrillators and implantable hip joints. Marcia Crosse, director of the GAO Health Care division, pointed out that only one of the high-risk devices approved for marketing under 510(k) was addressed through FDA issuance of a new final rule requiring a more rigorous approval process, whereas 26 high-risk devices remain approvable through 510(k).

Although the GAO reiterates its lingering concern that FDA still permits class III devices to be approved via the less rigorous 510(k) process, it turned its focus on the shortcomings of FDA’s oversight of device recalls in the April 2011 testimony. The GAO made the following points regarding these shortcomings:

  • FDA has not routinely used recall data to aid its oversight of the recall process;
  • FDA inconsistently assessed the effectiveness of recalls;
  • FDA lacks specific criteria to determine whether firms have taken adequate steps to correct or remove recalled devices;
  • FDA’s recall termination process is compromised by weak procedures and may result in recalled medical devices remaining on the market

Moreover, looking at the GAO web page that addresses overarching concerns regarding FDA’s oversight of all medical products, it is clear that GAO views globalization of medical products as posing additional challenges for FDA in its regulation efforts.