FDA BRIEF: Week of September 19, 2016

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SCOPE : For coordinated development of new antimicrobial drug and an antimicrobial susceptibility test (AST) device to streamline CDER and CDRH reviews and approvals

  • Interactions between drug sponsors and device manufacturers
  • Considerations for submitting separate applications to CDER and CDRH
  • Clarify independent review of drug product and device
  • Maximize  likelihood of coinciding device and drug approvals

CONSIDERATIONS FOR COORDINATED DEVELOPMENT

  • Submit coordinated development plans to CDER and CDRH, respectively, for review and comment
  • Joint meetings with  drug sponsor and device manufacturer and personnel from both CDER and CDRH
  • Use CDRH pre- submission process
  • CDRH communicate with CDER and review the 510(k) submission during the NDA review process

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SCOPE

  • Computational Modeling and Simulation (CM&S) studies to support device design/development and CDRH submissions
  • Provide recommendations formatting, organization, and content of  CM&S reports
  • Improve consistency and predictability of FDA review

TRADITIONAL USE

  • Fluid dynamics
  • Solid mechanics
  • Electromagnetics and optics
  • Ultrasound propagation
  • Thermal propagation

CM&S REPORT OUTLINE

  •  Executive Report Summary
  • Background/Introduction
  • Code Verification
  • System Configuration
  • Governing Equations/Constitutive Laws
  • System Properties
  • System Conditions
  • System Discretization
  • Numerical Implementation
  • Validation
  • Results
  • Discussion
  • Limitations
  • Conclusions

READ


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PURPOSE

  • TKV: Sum of the volume of the left and right kidneys
  • Qualified context of use (COU) for TKV in studies for the treatment of autosomal dominant polycystic kidney disease (ADPKD)

CONTEXT OF USE

  • Use Statement:  Prognostic enrichment biomarker,  TKV-based patient selection

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