FDA launches expedited approval for kidney-disease devices

The Food and Drug Administration said Monday it will work with certain makers of kidney-disease devices to speed up approval of their products and announced the winners among 32 applicants to the program.

The Center for Devices and Radiological Health's "Innovation Pathway" was first announced in February 2011 as a pilot program. The first batch of submissions was for brain-controlled, upper-extremity prosthetics.

The pathway program works within the existing regulatory framework, the FDA explains, while engaging with innovators earlier in the process in order to shorten the overall time and cost it takes for the development, assessment and review of breakthrough medical devices and to improve how FDA staff and innovators work together.

The three winning products announced Monday are: 

• an implantable Renal Assist Device (iRAD) being developed by the University of California, San Francisco; 

• a Wearable Artificial Kidney (WAK) in development by Blood Purification Technologies Inc. of Beverly Hills, Calif.; and

• a Hemoaccess Valve System (HVS) that has been designed by Greenville, S.C.-based CreatiVasc Medical.

"The Innovation Pathway seeks to shorten the overall time and cost it takes not just for pre-market review, but for the development, assessment and review of breakthrough medical devices so these devices can get to the patients who need them sooner," the FDA said in a statement. "The pathway also seeks to improve how FDA staff and innovators work together."

The FDA chose end-stage renal disease for the program's next step because of the disease's cost to the healthcare system: more than half a million Americans suffer from the disease, with Medicare footing 75 percent of the $29 billion-a-year bill. Management of the disease is largely dependent upon medical-device technology, according to the FDA, such as hemodialysis equipment to remove waste products from the body.

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