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Innovation Initiative Remarks - Jeffrey Shuren, M.D., J.D., Director FDA's Center for Devices and Radiological Health

Feb. 8, 2011

According to a recent report by Price Waterhouse Coopers, the U.S. is the global leader in medical device development.

This didn't happen by chance. We're the leader in this field because we've combined our tradition of ingenuity and innovation with our desire to help and to heal.

Being leaders in medical device development has obvious economic benefits for the country. It benefits American patients, too, by getting them the latest technology and next-generation products in a timely way.

But we won't remain the world's leader for long if we do not invest in both innovative science and innovative oversight.

To successfully achieve our mission to promote and protect the public health means to strike the right balance between innovation and safety.

We must assure that our oversight doesn't stifle innovation-but rather, encourages innovation while maintaining a commitment to safety and effectiveness upon which Americans rely and that other countries follow. We must turn what has long been considered the Valley of Death into the Pathway to Success.

We can accomplish this by providing clarity and predictability in our regulatory expectations so industry knows what they must do.

We can accomplish this by putting our considerable experience and knowledge to use to help industry bring safer, more effective devices to the American public.

We can also accomplish this by identifying and facilitating the development and assessment of truly ground-breaking technologies.

Today we are proposing an Innovation Initiative that builds on work we've already done over the past year to set the ever swinging pendulum in the right place between innovation and safety.

The Innovation Initiative will address three main goals:

First, it will help accelerate the development and regulatory evaluation of innovative devices that have the potential to transform an area of health care and address an unmet medical need.

Second, it will strengthen the U.S. research infrastructure and promote high-quality regulatory science.

Finally, it will help the FDA better prepare for and respond to transformative technologies and scientific breakthroughs.

Details on the Initiative and how it addresses these goals are outlined in a report we published today on our website.

I'd like to take a few minutes to talk about some of the Initiative's proposed actions that speak directly to the agency's commitment to building a tradition of innovation and safety.

Perhaps most exciting is our proposal to establish a priority review program for eligible, new medical devices that demonstrate the potential to revolutionize disease treatment, diagnosis, or health care delivery and that target unmet medical needs.

Under the Innovation Pathway, the FDA's medical device center would commit time and resources much earlier in product development so that innovators of new, safe and effective technologies can reach the U.S. market more quickly and efficiently.

We will choose and monitor qualified project applications through the new Center Science Council, which will be comprised of medical device center senior managers and experienced staff.

We will assign a “case manager,” to each selected product to help the sponsor navigate the Innovation Pathway and establish a primary review team earlier in the development process. Within 120 days from acceptance into the pathway, the review team, using an interactive process, will develop a memorandum with the sponsor that describes a proposed roadmap and timeline for device development, assessment, and regulatory review.

Because these are novel technologies it is likely they will raise new scientific and regulatory challenges. So, key features of this pathway will be identifying and resolving these issues early, in part by leveraging scientific expertise outside of the agency from a new Network of Experts we are in the process of creating.

Clinical trial protocols would be developed by the sponsor and the Center through an interactive process and have flexibility built in to allow for repeat testing and redesign.

By front-loading our resources, we can reduce unnecessary delays and review these devices for approval in roughly half the time it takes for the typical premarket approval, or PMA, application.

Just to be clear, devices that utilize the Innovation Pathway must still adhere to the regulatory standards for new applications.

Just because a device is accepted into the pathway doesn't mean it's destined for approval. To assure that the Center continues to help drive the development of pioneering devices, I've created a new senior position -- Associate Director of Technology and Innovation - and have named Dr. Jonathan Sackner-Bernstein to that post.

While the Innovation Pathway will help revolutionary technology under development realize its potential, there are other parts of the Innovation Initiative that we think can also advance medical device development.

To remain the world's leader in device innovation, we must have a robust research infrastructure in this country and promote high-quality regulatory science - the science of developing new tools, and approaches to assess the safety, effectiveness, and quality of medical devices.

One of the ways we propose to strengthen device research is by creating a voluntary third-party certification program for medical device test centers across the country. Eligible test centers would have expertise in both device design and the conduct of high-quality clinical studies.

Unlike a drug whose active ingredient does not change and whose inherent flaws cannot generally be fixed, a device can be improved through changes to its design or composition at any time.

By incentivizing universities and other institutions in a competitive way to combine expertise in developing and in assessing devices, they can help find and fix problems earlier.

In addition, because certified test centers would have well established safety records, we would permit them to conduct first-in-human studies at an earlier stage in device development. As a result, the device development process would become more predictable, safer, and less costly.

We also need to invest in people.

Unlike for the pharmaceutical sciences, the U.S. education system has few programs in device development. To train future innovators, we will work with academia, industry, and the health care community to develop a publicly-available core curriculum in device design, testing, regulatory processes, and postmarketing surveillance.

And we need to expand our efforts to develop new regulatory science.

CDRH has 20 laboratories with roughly 130 scientists, engineers, and clinicians actively engaged in about 70 regulatory science research projects, such as developing more accurate methods to measure the effects of new anticancer treatments on tumor size and creating computer models that may help reduce the number of people on whom an experimental device must be tested.

In the coming year we'll be announcing partnerships that leverage government and private sector resources to create new tools to accelerate the development, testing, and manufacturing of tomorrow's medical breakthroughs.

Another way we propose to strengthen regulatory science is by providing clear guidance on how sponsors can best leverage data and research conducted outside of the United States.

A great deal of research today is conducted overseas. Over the years, we've had difficulty accepting much of this data for a number of reasons, including issues related to poor quality and non-applicability to the U.S. population.

We will provide industry with clear guidance on criteria and circumstances under which data developed overseas could be used to support device submissions. More clarity in this area could result in better data and less of a need to conduct additional clinical studies.

This often means a smoother review, less cost to companies, and fewer risks to patients from investigational devices.

We will be discussing the Innovation Initiative at a public meeting on March 15, 2011. We will be looking for comments on the pathway, our plans for test center certification, guidance on overseas data acceptance, and the several other critical pieces of our innovation commitment.

This isn't an ordinary initiative and it's not the kind of proposal you're used to hearing from a regulatory health agency.

Much of what we do-the critical, necessary foundation of what we do-is focused on reviewing manufacturer submissions for premarket review, and monitoring devices already on the market for continued safety and effectiveness.

Last year, as part of our 2010 Strategic Priorities, the Center started a sea change in how we approach public health. We did this after taking time to listen carefully to what our constituents-industry, patients, health care professionals,-had to say about our operations at town hall meetings and other venues across the country.

We listened and responded.

We responded by taking strategic steps to move our Center from an effective - but mostly reactionary -regulatory body, to an innovative, government facilitator. We have begun to move strategically and methodically towards becoming a public health agency that uses our unique, regulatory vantage point to encourage opportunities for medical device innovation while, at the same time, strengthening the safety and effectiveness of existing and future devices.

We responded to the call for greater predictability and clarity by conducting a comprehensive review of our 510(k) program and how we use evolving science in our decision making.

Following this assessment, we announced, just a few weeks ago, 25 specific actions we will take this year to strengthen our premarket review programs by making them more predictable and transparent.

Unlike other countries, the FDA sees and reviews important information on medical devices both before and after they enter the U.S. market. When we share what we know we can make the next generation of devices and those already on the market safer and more effective.

We took this approach last year with infusion pumps, automated external defibrillators, and medical imaging technologies that emit radiation, such as CT scanners. Our efforts are starting to pay off. In the coming months we'll update the public on the progress we've made so far.

We also responded to requests for federal agencies to better collaborate to stimulate new technologies and better clarify requirements for their use in the U.S.

We established an interagency Council on Medical Device Innovation. We have formed new strategic alliances with Council members, such as with the Centers for Medicare and Medicaid Services to create a parallel review process, and with the Federal Communications Commission to clarify the regulations of wireless, mobile health care applications.

And today's Innovation Initiative is our response to requests to address unmet medical needs by proposing solutions for truly innovative technologies.

Encouraging and facilitating innovation isn't just about faster product review times-although expediency is key. It's about smarter regulation and sharing our experience and knowledge with industry and users to make devices better for patients and practitioners.

We must continue to transform the medical device center into a nimble and flexible agency that can continue to support the U.S. as the leader in medical device innovation and make good on our commitment to the health of the American public.