Consumer group demands major change in user fee bill

As the Senate gears up to vote on a bill to reauthorize medical device user fee legislation, the lobbying arm of Consumer Reports is stepping up its push to close what it says is a major loophole. Consumers Union wants the bill to require device makers to have to prove they've fixed any design flaws, when they want to market a new one based on an earlier model that had been recalled over safety issues. The group notes that the FDA doesn't have the power and said closing the loophole would help protect patients. Story

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