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Breakthrough Pathway Final Guidance Eases Sponsor-Regulator Interaction Requirements

US FDA issued a final guidance that sets out requirements for its new Breakthrough Devices Program mandated by Congress. Under the new program, which replaces the Expedited Access Pathway, sponsors have more certainty about how quickly they will get responses from the agency and fewer requirements when setting up early interactions.

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Two years after Congress passed the 21st Century Cures Act, US FDA has finalized a guidance that lays out a pathway that fast-tracks certain high-priority medical devices by easing interactions with regulators. And in one major part of the guidance, the agency outlines conditions for “sprint” discussions to ensure sponsors get quick responses to important development questions.

As part of the 21st Century Cures Act, lawmakers required FDA to develop a new pathway called the Breakthrough Devices Program. Similar to the Expedited Access Pathway (EAP) already in...

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