The U.S. Food and Drug Administration has chosen three products for patients with end-stage renal disease to participate in the Innovation Pathway, a new system designed to help medical devices reach patients in a safe, timely, and collaborative manner.
The FDA selected the following three products from 32 applications submitted in response to a January 2012 request from FDA”s device center:
- 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.
- A Hemoaccess Valve System (HVS) that has been designed by Greenville, S.C.-based CreatiVasc Medical.
The majority of the 32 applications came from small, start-up business or academic institutions.
“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 Jeffrey Shuren, MD, director of the FDA”s Center for Devices and Radiological Health.
The ESRD products will be the focus of the second version of the Innovation Pathway, first announced in 2011, to shorten the time and cost it takes for the development, assessment and review of medical devices, in particular breakthrough medical devices.
“We found ESRD a natural fit given that patients have few options. 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 health care, encouraging innovation through smarter regulation that could potentially save companies time and money,” said Shuren.
Developers who participate in what FDA now calls Innovation Pathway 2.0 have an opportunity to collaboratively discuss their technology with FDA, work with the agency on the development of a benefit-risk profile for their product that will help guide future studies and map out a regulatory path forward for their product.
This approach is intended to deepen collaboration between FDA and innovators early in the process, prior to pre-market submission, with the goal of making the regulatory and product development process more efficient and timely.