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U.S. Department of Health and Human Services

About FDA

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Critical Path Projects at CDRH FY 2010

  1. Development and Validation of a Standard Test Method to Assess for Impingement of Artificial Total Disc Replacement Devices (TDRs)
  2. Accelerating the Regulatory Process for Translation of Nanotechnology based Products into Medical Devices & Diagnostics
  3. Optimization of Preclinical Test Methods for Simulating the Degradation of Bioabsorbable Implants
  4. A New Paradigm in Medical Device Design and Evaluation - Leveraging the Simulation-Based Engineering and Medical Imaging Technology Revolutions in Critical Path Research
  5. Quality of Life and Significant Symptoms after LASIK
  6. Standardization of computational fluid dynamic (CFD) techniques used to evaluate performance and blood damage safety in medical devices
  7. Re-thinking Analytical Strategies for Surveillance of Medical Devices
  8. Optimizing Clinical Trial Design for the Development & Advancement of Pediatric Cardiovascular Devices: Workshop
  9. The assessment of molecular diagnostic assays as alternative reference methods for premarket evaluation of rapid molecular diagnostic devices for influenza
  10. Machine assisted signal detection using Semantic Text Mining
  11. Optimization of defibrillation in children using computational modeling
  12. Comparison of Image Quality and Dose using CT and Tomosynthesis modalities
  13. Can computer simulations of semi-autonomous drug administration devices with incorporated pharmacokinetic/pharmacodynamic models be used to improve premarket study design, enable prediction of the boundaries of personalized dosing and reduce post-marketing adverse events?
  14. The Application of Computational Intelligence in Medical Device Study: Developing a Composite Index Approach to Predicting Individual Patient Success Outcomes after Lumbar Disc Implantation
  15. Standardized use of Brain fMRI as a biomarker for Clinical Trials
  16. Assuring the safety and effectiveness of neurodiagnostic and psychometric devices (NPDs) for vulnerable patient populations: Workshops
  17. Development of a registry for intraocular lens implants: A method of surveillance for inflammatory syndromes and adverse events
  18. Risk-Benefit and Decision Analyses of Electro-Convulsive Therapy in Major Depression, Mania and Schizophrenia
  19. Enabling whole-slide digital microscopy by developing standard assessment methods for color, dynamic range and 3D viewing of pathology tissue samples
  20. Investigation of Multiplex Protein Arrays for Detecting Biomarkers Predictive of Chemotherapy Sensitivity-Resistance in Breast Carcinoma Patients
  21. Congenital Heart Disease Registry
  22. Safety of Live Case Presentation at Cardiovascular Conferences
  23. VA FDA SAFE (Survival Analysis of Existing) ICD Leads Collaborative Study
  24. Development of a Cardiac Electrophysiological Device Scientific Resource
  25. Average Treatment Effect Estimation Accounting for Covariate Measurement Error - New causal model technique with a medical device application: the Impact of Breast Pump Use on Mother’s Breast-Feeding Practice and Infant’s Health
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