Breakthrough Medical Devices and the 21st Century Cures Act

In 2012, Congress gave the U.S. Food and Drug Administration (FDA) authority to designate new drugs with promise of substantial benefit as "breakthrough" drugs and then take steps to expedite their pathway to possible approval. Congress is now deciding whether to give the FDA the authority to give medical devices the same designation. This article examines the risks, benefits, and ethical considerations of that decision.

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