The U.S. Food and Drug Administration (FDA) has reached an agreement in principle with medical device industry representatives on proposed recommendations for the third reauthorization of its medical device user fee program.
Under the deal, which was reached with the Advanced Medical Technology Association, the Medical Device Manufacturers Association, and the Medical Imaging and Technology Alliance, the FDA would be authorized 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, the FDA said. The agreement is the result of more than a year of negotiations between the FDA and industry.
