SILVER SPRING, Md., Feb. 8, 2011 /PRNewswire-USNewswire/ –Today
the U.S. Food and Drug Administration proposed the Innovation
Pathway, a priority review program for new, breakthrough medical
devices and announced the first submission: a brain-controlled,
upper-extremity prosthetic that will serve as a pilot for the
program. The FDA also announced plans to seek further public
comment before the Pathway can be used more broadly.
(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)
The new proposed Innovation Pathway program for pioneering
medical devices, highlighted in a report published on the FDA’s
website today, is part of a broader effort underway in the FDA’s
Center for Devices and Radiological Health (CDRH) designed to
encourage cutting-edge technologies among medical device
manufacturers.
The initiative will also seek to strengthen the nation’s
research infrastructure for developing breakthrough technologies
and advancing quality regulatory science. Proposed actions
include:
- establishing a voluntary, third-party certification program for
U.S. medical device test centers designed to promote rapid
improvements to new technologies during a product’s development and
clinical testing stages; - creating a publicly-available core curriculum for medical
device development and testing to train the next generation of
innovators; and - using more device experience and data collected outside the
United States.
In addition, CDRH intends to engage in formal horizon scanning
– monitoring medical literature and scientific funding in a
systematic way to predict where technology is heading. CDRH will
include public input in this process to prepare for and respond to
transformative innovative technologies and scientific
breakthroughs.
“Each year, millions of American patients benefit from
innovati
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