FDA to Streamline Approval for Medical Devices
Updated: Monday, 09 Apr 2012, 4:15 PM CDT
Published : Monday, 09 Apr 2012, 4:15 PM CDT
(NewsCore) - The US Food and Drug Administration (FDA) announced on Monday a plan to widen its efforts to cut the time and cost it takes to approve new medical devices.
FDA officials said they will be playing a larger role in the early stage of the approval process and weighing factors such as how much risk patients are willing to take with new devices.
"When patients are faced with a terminal illness, many of them are willing to accept more risk than they would in other circumstances," said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health. "Our intent here is to make those perspectives an explicit consideration in our decision-making."
Three devices to help patients with end-stage renal disease, such as an artificial kidney, are the initial targets of the latest iteration of FDA's Innovation Pathway program that officials said will expand further.
About half a million Americans suffer from end-stage kidney disease and medical devices play a large role in treatment. The disease rapidly robs the function of a person's kidneys, which filter and remove waste from the body.
"We think this process could impact the lives of patients by providing access to innovative new technologies they so desperately need," Shuren said. "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."
Jack Lasersohn, a partner in The Vertical Group, a venture capital company focused on medical technology and biotechnology, said the increased collaboration with FDA could shave as much as a year off the time it takes in designing clinical trials.
The first version of the FDA's Innovation Pathway was announced about a year ago and dealt with only one device, an artificial arm controlled by a computer chip implanted in the brain.
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