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.
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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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