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U.S. Department of Health and Human Services

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Critical Path Projects at CDRH FY 2009

  1. Artificial Pancreas Critical Path Initiative
  2. Development of universal CDRH regulatory strategy for neurotoxicity testing to access new materials used in neurological devices that are in contact with cerebral spinal fluid and neural tissues
  3. Leveraging the Simulation-Based Engineering and Medical Imaging Technology Revolutions in Critical Path Research
  4. Standardization of computational fluid dynamic (CFD) techniques used to evaluate performance and blood damage safety in medical devices
  5. Biomarker Development for Evaluation of Device Interventions for Recovery from Heart Failure
  6. Better Safety Biomarkers of Acute Kidney Injury to Improve Public Health and Product Approval
  7. Assessment of Patient Satisfaction and Quality of Life after LASIK surgery
  8. Standardized CT Protocols for Lung Cancer
  9. Software for Bayesian Clinical Trials
  10. Accelerating the Regulatory Process for Translation of Nanotechnology based Products into Medical Devices and Diagnostics
  11. Optimization of Preclinical Test Methods for Simulating the Degradation of Bioabsorbable Implants
  12. Development of Total Artificial Disc Impingement Test Standard
  13. In-vivo Measurements of Cardiac annular Forces in Sheep in order to Provide Scientific Basis for Regulatory Guidance for Percutaneous Heart Valves