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Announcement of the CDRH Medical Device Innovation Initiative

Remarks of Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
Medical Device Innovation Initiative Announcement
February 8, 2011

Good afternoon. It's a pleasure to speak with you today on the topic of innovation.

Unfortunately, my schedule will not allow me to stay for the full duration of this briefing, but I did want to help open it. Because today’s announcement has broad implications for how the FDA does business and how we support—and will continue to support—important opportunities for innovation. And as you will soon see, these quite extraordinary opportunities as well.

More broadly, this is a critical moment for innovation for our agency—and for our nation. The pace of biomedical discovery continues to accelerate and the stakes have never been higher. By the end of the decade, a combination of trends, including international competition, will test America’s role as the global leader in medical product innovation. And, as a nation, we have important choices to make about how to move forward.

As we do, the FDA is eager and prepared to help lead the way.

Our agency is charged with a very significant task: to protect and preserve the health of the American people. And to succeed in that mission, we must not only ensure the safety and efficacy of our nation’s supply of drugs and other medical products and also the safety and wholesomeness of food—but also foster the scientific innovations that make these products more new and better for the American people.

Both roles are essential to delivering progress for patients and consumers—and also impact our economy by encouraging consumer confidence, growing key industries, and creating jobs.

Of course, innovative products that are truly transformative create new and unique scientific and regulatory challenges. So we at FDA are rolling up our sleeves and proactively rising to these challenges. We want to ensure that our agency is a consistently powerful catalyst for innovation. And the initiative we’re announcing today is at the forefront of that effort.

As you will hear from my colleagues in a few moments, CDRH’s Medical Device Innovation Initiative includes a novel priority review pathway for bringing pioneering medical devices to market, swiftly and safely. And, notably, it promotes the exchange of ideas among external and internal innovators, device experts, and FDA staff—building a framework for recognizing promising ideas early and incentivizing innovation for years to come.

In fact, the pilot device for the priority review pathway is an example of this spirit of collaboration—and a product of a recent Memorandum of Understanding with the Defense Advanced Research Projects Agency, or DARPA, an agency of the U.S. Department of Defense responsible for the development of new technology.

This initiative is an important step for our agency. And it is an important step for the future of innovation in medical devices and beyond. In the months and years to come, we will continue to apply the key principles of this initiative—a predictable, streamlined regulatory pathway and a strong science base—to all of FDA’s work and, more broadly, to fulfilling our fundamental public health mission.

So I’m very pleased that you’re with us to hear about this important new initiative and I thank you for your time.