Federal health officials have proposed a plan that would speed up the approval of innovative medical devices that hold the potential to dramatically improve patients' lives.
The so-called Innovation Pathway from the Food and Drug Administration would aim to review first-of-a-kind devices in five months, which is half the time currently spent reviewing most new devices. The initiative comes amid complaints from medical device manufacturers that FDA review times lag behind other regulators abroad.
Medical device executives say it takes the FDA about twice as long to review new devices as their counterparts in the European Union, according to an industry survey released last month by PriceWaterhouseCoopers.
The FDA said an innovative prosthetic arm developed by the Department of Defense would be the first device to use the new system.
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