April 17, 2012 - 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." This program offers new and modified tools and methods to deepen collaboration between the U.S. Food and Drug Administration (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.
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.
“Patients deserve faster access to safe and effective medical devices that address unmet public health needs,” said Kathleen Sebelius, secretary of the U.S. Department of Health and Human Services (HHS). “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 United States by giving them first-in-the-world access to medical devices, including those with breakthrough technology.”
For more information: www.fda.gov
November 25, 2025 
