FDA, Medical Device Industry Reaches Agreement on User Fees

Posted: February 03, 2012 by David Rosenfeld

The Food and Drug Administration announced Wednesday it had reached an agreement on recommendations to reauthorize medical device user fees.

The agreement with industry representatives means the FDA could collect $595 million in fees over five years to fund FDA’s device review program, according to a press release. The exact fee schedule has yet to be released.

Earlier this week, six former employees who reviewed medical devices alleged retaliation by FDA senior management for opposing certain diagnostic imaging devices.

The reauthorization of user fees will allow the FDA to employ 200 full time workers to conduct reviews. Industry trade groups involved in the discussions with FDA included Advanced Medical Technology Association, the Medical Device Manufacturers Association and the Medical Imaging and Technology Alliance.

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