Patients deserve faster access to safe and effective medical devices
that address unmet public health needs. The FDA's Innovation Pathway is a
new way of doing business within our existing regulatory framework that
could yield significant benefits to patients in the U.S. by giving them
first-in-the-world access to medical devices, including those with
breakthrough technology.
The Innovation Pathway is an evolving system designed to help safe,
breakthrough medical products reach patients in a timely manner. The
Pathway ultimately aims to shorten the overall time and cost it takes
for the development, assessment and review of medical devices, and to
improve how FDA staff and innovators work together.
By engaging with innovators much earlier, more collaboratively, and
in new ways, we believe we can reduce the time and cost of the entire
process of bringing safe and effective technologies to patients more
quickly.
On April 9, 2012, the FDA's Center for Devices and Radiological
Health (CDRH) launched its second version of the Innovation Pathway,
called "Innovation Pathway 2.0."
Innovation Pathway 2.0 offers new and modified tools and methods to
deepen collaboration between the FDA and innovators early in the
process, prior to pre-market submission, with the goal of making the
regulatory process more efficient and timely.
The Pathway also serves as a living laboratory to test new tools and
methods for breakthrough devices that we may also apply to other
technologies to enhance all of our device pre-market programs.
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHInnovation/InnovationPathway/default.htm?utm_source=fda&utm_medium=website&utm_term=InnovationPathway&utm_content=f2&utm_campaign=HomePageSpotlight
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