Devicemakers Agree to Pay Almost $1 Billion Under MDUFA IV

The FDA and the medical device industry have agreed on the terms for a new medical device reauthorization package that would authorize the agency to collect $999.5 million in user fees over the next five years. 

Effective Oct. 1, the draft agreement marks the fourth reauthorization of the medical device user fee program.

Under the new agreement, the FDA would be authorized to collect $999.5 million in user fees plus adjustments for inflation over five years.

Details of the draft agreement will be published in the next few weeks, and the final recommendations are scheduled to be delivered to Congress in January 2017.

The MDUFA IV agreement does not change user fees announced for fiscal year 2017 that were released in late July. — Tamra Sami