Industry, FDA Move Forward on MDUFA IV Priorities

With negotiations on the fourth installment of the Medical Device User Fee Amendments moving ahead, medical device companies appear to be pleased with how the process is progressing, at least according to one industry insider.

“Industry, from what I understand, is happy with the way it is going,” says Matthew Weinberg, CEO of The Weinberg Group in Washington, D.C. His comments come ahead of a Nov. 18 meeting, during which FDA officials and industry stakeholders will continue discussions to move the process forward.

The process kicked off at a July meeting at the agency’s White Oak campus in Silver Spring, Md., during which officials heard feedback from industry about what worked well during MDUFA III, as well as what could be improved (IDDM, July 17). Subsequent meetings examined the agency’s guidance process and capabilities and limitations of the device center’s information technology systems.

At an Oct. 26 meeting, stakeholders and FDA officials nominated priorities for MDUFA IV, including: Incorporating patient perspectives in FDA reviews; using data from device and patient registries more efficiently for pre- and postmarket purposes; and coordinating FDA’s work in areas such as combination products and companion diagnostics to ensure adequate user fee funding.

Stakeholders are trying to make sure the rules are logical, Weinberg says. If they are going to continue to pay for user fees, they want to make sure they are getting what the FDA promises, he adds. “The real question is, will the agency work in timely manner and allow for appropriate throughput of products as MDUFA promises,” Weinberg tells IDDM.

The Oct. 26 meeting minutes on MDUFA IV negotiations are here: www.fdanews.com/11-15-MDUFA-Meeting.pdf. — Jonathon Shacat