Industry, FDA Hammer Out MDUFA IV Programs

Devicemakers and FDA are inching towards an agreement over MDUFA IV goals, but industry says additional resources and infrastructure are needed to achieve those goals.

AdvaMed, MDMA and MITA presented proposals that would provide FDA with $680 million including inflation to meet FDA’s current performance goals, plus an additional $131 million spread over five years to support the 91 FTE’s needed.

FDA acknowledged that industry’s proposals were a step in the right direction but the agency didn’t address additional resources or staffing, according to MDUFA meeting minutes posted on the FDA’s website May 26.

Industry’s proposal lies in bulking up FDA’s workforce to improve on the time it takes the agency to reach decisions on 510(k) and PMA applications by the end of 2022.

The proposal included resource estimates for several areas, including pre-submissions, quality management, total product life cycle, de novo, CLIA waivers, independent assessments, IT improvements, recruitment, third-party review programs, digital health, and standards.

Industry did not address real world evidence, patient engagement and manager incentive pay proposals, and stakeholders said they needed more information to address these topics, meeting minutes indicated.

Furthermore, industry proposed an additional $6 million for an “independent assessment” of the review process; $4.5 million for development of a “myDevices” portal for device sponsors as proposed by ACLA; $2.5 million to improve FDA’s recruiting processes through external recruiters; and $4 million to boost the agency’s third-party premarket review program.

FDA stressed that industry’s proposal was incomplete based on the agency’s estimated analysis of prior program performance and trends.

The agency also said that industry did not include IT operating dollars in their resource estimates. FDA said that without user fee support for the necessary changes to legacy IT systems, FDA would not be able to implement IT changes for the review program to reflect MDUFA IV processes and performance goals.

View the meeting notes here: www.fdanews.com/05-27-16-427MDUFAIVMeetingNotes.pdf. — Joya Patel