FDA clears a path for new kidney disease tech

Jeffrey Shuren, M.D.

The FDA is moving to give technology to treat end-stage kidney disease a push down the pipeline amid criticism that the agency moves too slowly in approving medical devices. The Innovation Pathway program, launched in 2010 aims to reduce time and cost of bringing safe and effective breakthrough technologies to patients.

Of 32 applications--most submitted by small, start-up business or academic institutions--the agency chose three medical devices to pilot:

  • An implantable Renal Assist Device being developed by the University of California, San Francisco.
  • A Wearable Artificial Kidney in development by Blood Purification Technologies Inc. of Beverly Hills, Calif.
  • A Hemoaccess Valve System that has been designed by Greenville, S.C.-based CreatiVasc Medical.

The FDA is focusing on end-stage renal disease (ESRD) because of its prevalence, the fact that it's expensive to treat, and because management of the disease is largely dependent on medical device technology, according to an FDA announcement.

"We found ESRD a natural fit given that patients have few options," Jeffrey Shuren, M.D., director of the Center for Devices and Radiological Health, said. "We think this process could impact the lives of patients by providing access to innovative new technologies they so desperately need. In turn, this could also have a positive impact on healthcare, encouraging innovation through smarter regulation that could potentially save companies time and money." 

Meanwhile, in a report report released today, the Government Accountability Office critized the FDA for not moving swiftly enough to approve medical devices. GAO officials studied the medical device clearance process and said FDA has gotten substantially slower at processing 510(k) applications, and is "inconsistent" in handling pre-market approvals.  

To learn more:
- see the FDA announcement
- read the GAO report     
- get details about the Innovation Pathway program

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