According to the GAO report, the FDA doesn’t have criteria for measuring whether manufacturers actually pull every defective device during recalls. Agency officials sometimes disagree about whether similar recalls have worked, the report says.
The agency also does not document its reasons for determining that recalls are complete.
“If unaddressed by FDA, the combined effect of these gaps may increase the risk that unsafe medical devices could remain on the market,” the GAO report states.
The FDA, like almost every domestic agency, would face a major budget cut under House Republicans’ 2012 spending plans. Separately, Congress will vote next year to reauthorize the fees that device-makers pay to fund FDA approval decisions for new products.