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FDA Opens Innovation Pathway to First Round of Devices

Posted 10 April 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is announcing its intention to open up its experimental Innovation Pathway to three medical device companies developing therapies for end stage renal disease (ESRD).

FDA's 9 April announcement said the three organizations-CreatiVasc Medical, Blood Purification Technologies Inc. and the University of California-were among 32 product applications covering a wide range of applications.

 "The response from innovators exceeded our expectations and demonstrates that there is a desire from developers of innovative technologies for earlier and more collaborative agency interaction," said Jeffrey Shuren, MD, director of the Center for Devices and Radiological Health (CDRH) at FDA.

Shuren said in a statement posted to FDA's FDA Voice blog it chose the ESRD devices as a result of their potential impact-more than half a million Americans suffer from the disease, characterized by progressive kidney failure-and ESRD's dependency on medical device technology.

"We think the Innovation Pathway can help medical technology reach patients with unmet medical needs such as those suffering from ESRD," said Shuren. "But, equally as important, we want to apply what we learned from our Innovation Pathway experience throughout our device review processes."

The three organizations will now have the opportunity to "collaboratively discuss their technology with FDA, work with the agency on the development of a benefit-risk profile for their product that will help guide future studies and map out a regulatory path forward for their product," explained FDA in a statement.

Read more:

FDA - Balancing Innovation and Safety: FDA's Innovation Pathway

FDA announces plans to pilot end-stage kidney disease technology in new program

Reuters - FDA program to foster innovation starts with kidneys

Modern Healthcare - FDA picks three renal-disease devices for fast-track review

The Hill - FDA launches expedited approval for kidney-disease devices

Bloomberg Businessweek - Kidney Failure Devices to Receive Fast-Track FDA Reviews

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