The Food and Drug Administration announced the Innovation Challenge on Friday, a pilot program for real-time review of devices that address end-stage renal disease or ESRD.
The pilot will test the tools and processes being developed for the Innovation Pathway, a program that aims to shorten the overall time it takes for the development, assessment and review of breakthrough medical devices.
The ESRD pilot will help the FDA assess the strengths and weaknesses of these tools and fine-tune them for broader application.
The challenge focuses on ESRD for a number of 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 U.S.