New Regulatory Science Needed, Hamburg Says

Citing home glucose monitors for diabetics as an example, FDA Commissioner Margaret Hamburg says the FDA must develop a new form of regulatory science to keep pace with technological innovation and ensure devices are safe and effective. “There has been no improvement in the accuracy of the monitors in the last decade,” she said at the closing of the Regulatory Affairs Professionals Society conference. “The FDA has requested that the International Organization for Standardization tighten this but is prepared to act on its own if it does not.”
Devices & Diagnostics Letter