News | April 17, 2012

FDA Launches New Innovation Pathway for Devices

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

Related Content

Technology | Focused Ultrasound Therapy | June 19, 2018
EDAP TMS SA has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Focal One device for...
Epsilon Imaging Demonstrates Strain Imaging Integration for Echo Programs at ASE 2018
News | Cardiovascular Ultrasound | June 19, 2018
Clinical practice, along with guidelines and research, have shown that speckle tracking strain imaging can improve...
FDA Clears Bay Labs' EchoMD AutoEF Software for AI Echo Analysis
Technology | Cardiovascular Ultrasound | June 19, 2018
Cardiovascular imaging artificial intelligence (AI) company Bay Labs announced its EchoMD AutoEF software received 510(...
Report Finds Identifying Patients for Lung Cancer Screening Not So Simple
News | Lung Cancer | June 18, 2018
New findings in the current issue of The American Journal of Managed Care suggest that getting the right patients to...
Weight-Bearing CT International Study Group Hosts  Scientific Session at AOFAS Conference
News | Computed Tomography (CT) | June 15, 2018
June 15, 2018 —The Weight-Bearing CT International Study Group will host a scientific session on the benefits of weig
New U.S. Tariffs on Chinese Goods Include Imaging Equipment
News | Radiology Business | June 15, 2018 | Jeff Zagoudis, Associate Editor
The Office of the U.S. Trade Representative (USTR) released the much-anticipated list of Chinese-manufactured goods...
Florida Hospital First in State to Adopt NeuroLogica's BodyTom Elite CT
News | Computed Tomography (CT) | June 14, 2018
June 14, 2018 — NeuroLogica, a subsidiary of Samsung Electronics Co.
Hitachi Medical Systems Europe Named Imaging Supplier for London Prostate Cancer Program
News | Prostate Cancer | June 14, 2018
Hitachi Medical Systems Europe has been awarded the contract to supply six ultrasound systems as part of the RAPID...
Riverain Technologies Issued U.S. Patent for Vessel Suppression Technology
News | Computed Tomography (CT) | June 14, 2018
Riverain Technologies announced that the United States Patent and Trademark Office (USPTO) has awarded the company a...
360 Photos | 360 View Photos | June 14, 2018
This is a 360 degree image from the Canon Aquilion 64-slice...
Overlay Init