(FDA: Silver Spring, MD) -- The Food and Drug Administration (FDA) and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program.

The recommendations would authorize the FDA to collect $595 million in user fees over five years, plus adjustments for inflation. Details of the agreement, such as the fee structure, are expected to be finalized soon.

Under a user fee program, industry agrees to pay fees to help fund a portion of the FDA’s device review activities, while the FDA agrees to overall performance goals such as reviewing a certain percentage of applications within a particular time frame.

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