In what year did the FDA formally establish the Breakthrough Devices Program to expedite development and review of innovative medical devices?

In the rapidly evolving medical device industry, regulatory pathways significantly impact how quickly innovative treatments reach patients. The FDA established a special program to expedite the development and review of certain medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions. This program has transformed the product development timeline for many critical medical technologies. How well do you understand this important medical product development pathway?

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2011
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2020