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Hello, I'm Secretary of Health and Human Services
Kathleen Sebelius.
And I'm excited to announce a new way forward in
bringing breakthrough medical devices to patients
quickly, safely and efficiently.
The Food and Drug Administration represents
the world's gold standard for evaluating the safety
and efficacy of new medical devices - a fact that has
brought life-saving benefits to patients in need and
major advantages for American manufacturers.
But we also know that to maintain our leadership,
we must continue to streamline and modernize the
FDA's device approval process.
That's why, last year, the Center for Devices and
Radiological Health launched its Innovation Pathway.
Our goal was to shorten the time and cost it takes for
breakthrough medical devices to move through the pipeline
-- from development, through assessment, to final review.
We're also improving how FDA staff and innovators work
together.
And through the Entrepreneurs-in-Residence
program we have enlisted the brightest outside experts to
provide guidance and support.
This new Innovation Pathway approach has already
produced results and it's beginning to create a
culture that embraces change.
Last January FDA called on developers of End Stage
Renal Disease treatment technology to submit ideas
for review.
The interest far exceeded our expectations and a
number of applications are already under review.
It is clear: there is a need for earlier and more
flexible interaction between developers and the agency.
And, the Innovation Pathway has begun to provide that
approach.
Where once change happened slowly,
today we have made a commitment to continuous
improvement.
In the months and years ahead,
we will work together to refine and accelerate the
process that brings breakthrough medical devices
to market.
And through our recently launched Innovation Fellows
program, we're building on the successful teams we've
built with outside experts.
This new effort expands the approach,
pairing entrepreneurs from the private sector with our
own officials, to solve some of the most pressing health
challenges across the Department.
I look forward to seeing the great progress these efforts
produce and the lives they touch.
Thank you.