Medical device makers cheer speedier reviews by FDA


Minnesota's medical device makers are applauding a report that shows federal regulators are speeding up the approval process. MPR reports the Food and Drug Administration says its backlog of devices waiting more than 90 days for a decision is down nearly two-thirds in a couple of years. A spokesman for the industry group LifeScience Alley calls it progress but says there's still a long way to go.

There's some worry that the process of approving medical devices could suffer a slowdown in the new year, depending on the outcome of Congress' "fiscal cliff" negotiations.

FDA steps aimed at shortening the approval process include a recent reorganization that broke the agency down into smaller divisions and branches.

But the FDA also defends its role in keeping ineffective or risky products off the market. In a report obtained by the Star Tribune last spring, regulators boast of protecting Americans from unsafe devices that were approved in Europe.

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