New User Fees Will Expedite Med Device Reviews

Source: MassDevice (7/9/12)

"The deal boosted the user fees from $295 million over five years to $595 million in exchange for the FDA meeting performance goals."

MassDevice

President Barack Obama signed the Food & Drug Administration Safety & Innovation Act, enacting the doubling of the user fees medical device companies pay to have the FDA review their products.

President Barack Obama put his pen to the Food & Drug Administration Safety & Innovation Act today, making it the law of the land that the user fees medical device companies pay to have the FDA review their products more than doubles.

The med-tech industry and the federal watchdog agency spent months hashing out the terms of the deal, which ultimately boosted the user fees from $295 million over five years to $595 million, in exchange for the FDA meeting performance goals. . .View Full Article

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