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'Breakthrough' Blueprint: US FDA Draft Guideline Outlines Revised Expedited Development Program

Executive Summary

The Breakthrough Devices Program is the established Expedited Access Pathway with some statutory updates, including the addition of 510(k)-pathway devices. But FDA also uses the congressionally-mandated draft guidelines to outline some new features in the program that are not in the statute, including a process for "breakthrough device sprint discussions."

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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.

Breathing Easy: ALung CEO Talks Novel Hemolung Device, FDA's Breakthrough Pathway, Landmark US/UK Clinical Trials

In a deep-dive sit-down interview with Medtech Insight, ALung Technologies CEO Pete DeComo dishes on US FDA's Breakthrough Devices Program and explains why his firm's novel artificial lung device, Hemolung, is worthy of traveling the expedited pathway to agency approval. DeComo also details two pivotal Hemolung clinical trials in the US and UK, and explains why Hemolung isn't marketing the device for commercial use despite being approved in 36 countries outside the US. He also talks about a future portable version of Hemolung, but noted that's not where ALung is focused right now. "Our first task is that first-generation technology – to get it to market, make it the standard-of-care, and then, if you are successful with all of that, you can do all of those wonderful other things as it relates to portability and wearability," DeComo says.

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