By Bill Gillette
The FDA has proposed a new system to streamline the approval process for innovative medical devices, Bloomberg Businessweek reported last week.
The Innovation Pathway program is designed to review first-of-a-kind devices in 5 months, about half the time it takes now, according to the Associated Press. A prosthetic arm will be the first product assessed under the new system.
The FDA speeded up its approval process for drugs nearly 20 years ago, but medical device manufacturers have long complained about the glacier-like pace of getting devices approved.
According to a recent PricewaterhouseCoopers survey, the United States is ranked the seventh-slowest nation in terms of approving medical devices.
The FDA will hold a public meeting March 15, 2011, to seek comments about the new program.
[Source: Modern Medicine]
