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FDA speeds pace of device OKs

Article-FDA speeds pace of device OKs

Washington — The Food and Drug Administration (FDA) has proposed a new system to streamline the approval process for innovative medical devices, Bloomberg Businessweek reports.

The Innovation Pathway program is designed to review first-of-a-kind devices in five 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 to seek comments about the new program.

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