MDUFA IV Reauthorization Meeting Summaries
FDA Brief: Week of Feb 22, 2016
KEY DISCUSSIONS : FDA’s and Industry’s proposal packages for MDUFA IV reauthorization
FDA Proposal: Cost Estimate of Industry 2015 Proposals
Industry Proposals:
- Process Improvement and Independent Assessment
- Review Summaries Proposal
- Pre-Submission Proposal
- PMA Proposal
- De Novo Proposal
- CLIA Proposal
KEY DISCUSSIONS
Integrated Infrastructure Proposal
- Managerial Retention and Oversight: Implement effective recruitment and hiring
- Quality Management: Establish a Quality Management team
- IT Modernization: myDevices Portal and eSubmitter
Integrated Process Improvements Proposal
- Integrated Review Process: Shift compliance and surveillance activities into ODE
- Device Coordinators: Ensure consistency in process, feedback through reg lifespan
- Review Summaries Proposal: Revised for 510(k) review summaries
Integrated Performance Proposals
- Q-Submissions: Revised proposals to improve success and timeliness
- De Novo: Steadily improve performance target to a decision within 120 days
- Third Party 510(k) Review: Proposal to strengthen program via analysis and training
- CLIA Waiver: Steadily increasing performance target to a decision within 180 days
Integrated Innovation Proposals
- Digital Health: Consistent review of software and issues related to digital health
- Device-Specific Guidance: Streamline guidance development and updates
- Leveraging Standards: Accreditation scheme for conformity assessment
- Real World Evidence: Enable reviewers to use evidence for decision-making
- Patient Input: Useful for benefit/risk evaluation