Food & Drug Administration commissioner Margaret Hamburg is pushing for tougher international standards governing the accuracy of blood sugar monitors, the Wall Street Journal (paid) reported.
Hamburg told a conference of regulatory-affairs professionals in Philadelphia that the FDA asked the International Organization for Standardization to toughen its requirements for the devices, which allow for 20 percent inaccuracy.
“If we’re unable to convince the international community to tighten the accuracy standards for glucose meters,” the FDA may require “higher performance standards ourselves,” Hamburg said, according to the newspaper.
Although the devices have been largely effective since débuting in the 1970s, Hamburg said the technology hasn’t changed much since over the last 10 years because manufacturers are content to meet ISO standards.