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FDA Data: Breakthrough Program Accepted 45% Of Applicants Since 2015

 
• By Elizabeth Orr

Data from the US Food and Drug Administration shows that the agency has granted 853 breakthrough device applications since 2015, out of 1,909 applications. The acceptance rate has varied from 33% in 2016 to 72% in 2017, with acceptance rates in recent years hovering around the 40% mark.

Young businessman breaking through a wall.
• Source: Shutterstock

Interested in the US Food and Drug Administration's breakthrough devices pathway? The odds may not be in your favor. Data from the agency shows that of almost 2,000 applications to the program and its predecessor since 2015, only 853 -- about 45% were granted the designation, with the other applications being either denied or withdrawn.

To qualify for the program, devices must provide more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition and meet at least one of four other...

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