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FDA’s Breakthrough Device Program: Opportunities and Challenges for Device Developers

As part of the 21st Century Cures Act, Congress gave the US Food and Drug Administration (FDA) the authority to establish a Breakthrough Devices Program intended to expedite the development and prioritize the review of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating disease or conditions. In December 2018, FDA issued a guidance document describing policies FDA intends to use to implement the Program. There are two criteria for inclusion in the Breakthrough Device Program: The device must provide for a more effective treatment or diagnosis of a life-threatening or irreversibly debilitating human disease or condition; and The device must (i) represent breakthrough technology, (ii) have no approved or cleared alternatives, (iii) offer significant advantages over existing approved or cleared alternatives, or (iv) demonstrate that its availability is in the best interest of patients....

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The Department of Transportation Helps Clear the Road for Autonomous Vehicles

The US Department of Transportation’s National Highway Traffic Safety Administration recently released A Vision for Safety 2.0, an update to its prior guidance on automated driving systems. The new guidance adopts a voluntary, flexible approach to regulation of automated driving systems and clarifies that it alone, and not the states, is responsible for regulating the safety design and performance aspects of such systems. Continue Reading

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