From the New Wire:
FDA and industry reach agreement in principle on medical device user feesThe 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. more..