FDA's Innovation Pathway

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

Balancing Innovation and Safety: FDA’s Innovation Pathway

Over the past couple of years, there has been a lot of discussion about balancing innovation and safety—whether we need to have more regulation of medical devices to assure safety and effectiveness—or whether we need less regulation of medical devices to foster innovation.
FDA’s Innovation Pathway is an exciting example of how innovation and safety and effectiveness don’t have to exist on opposite ends of a swinging pendulum. They can be complementary, mutually supporting aspects of our public health mission.
The goal of the Innovation Pathway is to reduce the overall time and cost it takes for the development, assessment, and review of safe and effective medical devices that address unmet medical needs, so these devices can get to the patients who need them sooner without jeopardizing patient safety.
Another goal is to improve how FDA and innovators work together. We can achieve that with our new Innovation Pathway through earlier engagement and more collaboration.

http://blogs.fda.gov/fdavoice/index.php/2012/04/balancing-innovation-and-safety-fdas-innovation-pathway/