FDA fast-tracks approval process of 3 kidney devices

The Food and Drug Administration announced plans to pilot a program meant to put new technology for end-stage renal disease in the hands of patients who need it.

The three products that have been chosen to participate in the FDA’s ‘Innovation Pathway’ program 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.

There were 32 product applications submitted, in total. The majority of the applications came from small, start-up business or academic institutions, according to the FDA.

“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 Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health (CDRH).

Innovation Pathway, a program that was first announced in 2011, is intended to shorten the time and cost it takes to develop, assess and review medical devices – especially those that could be considered breakthrough treatments.

End-stage renal disease is the loss of kidney function over months or years.  Kidneys are essential organs in the body, filtering and removing waste and producing hormones to aid in calcium absorption and red blood cell production.  More than half a million Americans suffer from the disease.

Click here to read more from the FDA.