A tentative agreement was reached in February between FDA and med-tech industry to increase the user fees medical device companies pay for agency review from $295 million over five years to $595 million in exchange for the FDA meeting performance goals.
“The agreement has the potential to be a game-changer because of its series of strong, measureable performance goals that will bring much-needed improvements to the efficiency and consistency of FDA’s medical device review process,” said Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association, in a news release issued after the agreement was reached. “It also provides FDA the resources it needs to meet the new goals.”
With the White House’s approval, the next reauthorization of MDUFMA will be subject to a 30-day public comment period and then will go to Congress for final approval.
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