A STAT Investigation

FDA’s breakthrough device program, meant to benefit patients, is delivering the biggest gains for companies

FDA’s breakthrough device program, meant to benefit patients, is delivering the biggest gains for companies

Five years ago, the Food and Drug Administration launched a new program with the best of intentions: to speed the development and review of cutting-edge and potentially lifesaving medical devices, all in the name of getting them to patients faster.

The initiative, known as the Breakthrough Devices Program, was set up to identify devices that the agency believed could provide “more effective” treatment or diagnosis for deadly and debilitating conditions than the current standard of care. And it came with perks: Among them, manufacturers of devices that receive the designation — more than 650 products so far — are given the opportunity to talk more often with regulators and design flexible clinical trials, potentially easing the path to market.

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