FDA Brief: Week of Feb 22, 2016


MDUFA2

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

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MDUFA1.JPG

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

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