FDA regulation

GUEST EDITORIAL By Thomas Cheplick, The Heartland Institute The Food and Drug Administration has issued a guidance document detailing a possible new regulation against off-label use of a category of medical devices, a development that stunned the device industry. The new FDA regulation would extend the legal doctrine called “intended use” to cover manufacturers of medical devices and make those manufacturers legally liable for off-label uses of their products. The FDA’s decision could have profound…