The FDA announced it is launching a new pilot program, called Innovation Challenge, for real-time review of devices that address end-stage renal disease. The agency said it hopes that this pilot will ultimately help people living with ESRD as well as other medical conditions.

The pilot will test the tools and processes being developed for its Innovation Pathway and possible application to other pre-market programs. It will help the FDA assess the strengths and weaknesses of these innovative tools and fine-tune them for broader application, the agency said.

The FDA said the Innovation Challenge focuses on ESRD for the following reasons:

•    ESRD is managed almost entirely using medical devices.

•    ESRD management is costly, and it negatively impacts the patient's quality of life.

•    ESRD is a growing public health care concern in the United States.

•    ESRD could benefit from innovative devices and transformative improvements.

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