MASSDEVICE ON CALL — The latest medical device user fee agreements are already working, according to FDA Commissioner Margaret Hamburg.
"We’re starting to see change already," Hamburg said last week after a gathering with Minnesota device makers and state Sens. Al Franken (D) and Amy Klobuchar (D). "This is sort of a critical moment, with the passage of the legislation."
The federal watchdog agency and the medical device industry worked together to forge an agreement on the next generation of user fee agreements with the Medical Device User Fee & Modernization Act.
The accord doubled the fees medical device companies will pay for agency review starting in 2013, from $295 million over 5 years to $595 million, in exchange for the FDA meeting performance goals.
The boost in fees allows the FDA to hire an additional 200 medical device reviewers and allot more resources for training and management, the Star Tribune reported.
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