FDA Innovation Pathway

In order to get patients faster access to safe and effective medical devices that address unmet public health needs, the FDA is developing what it calls the "Innovation Pathway." The Innovation Pathway will be a new way of doing business within the FDA's existing regulatory framework. The initiative is particularly focused on breakthrough technology.

The primary goal for the new Innovation Pathway is to shorten the overall time and cost it takes for the development, assessment and review of medical devices.  The FDA also seeks to improve how FDA staff and innovators work together.  Engaging with innovators much earlier, more collaboratively, and in new ways, should help to reduce the time and cost of the entire process.

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."  According to the FDA, 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.


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