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Critical Path Research: Getting New Technology from Bench to Bedside A Device Perspective FDA Science Board November

Critical Path Research: Getting New Technology from Bench to Bedside A Device Perspective FDA Science Board November 5, 2004. Dan Schultz Director, CDRH. Establish reasonable assurance of the safety and effectiveness of medical devices marketed in the U.S. Role of FDA. HHS/FDA/CDRH.

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Critical Path Research: Getting New Technology from Bench to Bedside A Device Perspective FDA Science Board November

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  1. Critical Path Research: Getting New Technology from Bench to BedsideA Device PerspectiveFDA Science BoardNovember 5, 2004 Dan Schultz Director, CDRH

  2. Establish reasonable assurance of the safety and effectiveness of medical devices marketed in the U.S. Role of FDA

  3. HHS/FDA/CDRH What is a “Device”?

  4. A Computer You Can Swallow

  5. A Computer That Helps You Hear

  6. Devices that Measure Glucose Levels and Deliver Insulin to “Communicate”

  7. Miniaturized Electrical Stimulators Pacemakers

  8. Drug-Eluting Stents Components • Stent Platform & Delivery System • Carrier(s) • Drug

  9. New Technology • Important Trends • Miniaturization • Intelligent Devices • Designed for Consumer Use • Minimally invasive • Biotechnology Revolution • Genomics, Proteomics • Biological Medical Devices • New Materials • Combination Products • Disruptive Technologies • That change how we do business • That change how medical devices deliver value

  10. CDRH Vision – Total Product Life Cycle

  11. Drugs Pure molecules Toxicology Short half-life Long market life Drug interactions Wrong Drug / Dose Clinically studied Good Manufacturing Practices (cGMP) Devices Complex components Biocompatibility Durable Equipment Rapid product cycles Malfunction User Error Bench studied Quality Systems (ISO 9000) Devices are Different

  12. Critical Path is Different for Devices • Device Regulation • Least Burdensome Provision of FDAMA • Quality Systems and Design Controls • Device Innovation Process • Biocompatibility • Iterative Process • User learning curve • Performance and durability • Device Industry is Represented by Small Manufacturers

  13. Medical Device Industry GrowthNumber of Manufacturers by Year Dun & Bradstreet Medical Device Firm Data

  14. Sales Volume Growth(Billions of Dollars) Note: No Economic Adjustment to Dollar Value

  15. Device Industry Continues to Grow in FY 04 • Dun and Bradstreet FY 04 data shows the device industry grew from 13,579 to 14,937 firms with about $320 billion in sales. • Innovation is alive and well! • 20% annual turnover in individual device firms. • FDA-industry interaction is more important than ever. FDA needs to keep guidances and reviewers up to date.

  16. Innovative Science-based Strategies at Work • Leveraging • Breast Cancer (DMIST): Screening and Digital Mammography • Medical Device Fellowship Program • Objective Performance Criteria • Heart valves • Hip implants • Novel Trial Designs • Bayesian Statistics • ROC Curves • Guidance Development

  17. Comparison of 510(k) Average Review Timesfor Devices With and Without Guidance* 140 106 Days (n = 1,021) (n = 623) *Based on all 510(k)s (1,644) with SE decisions during FY 2002 that were for Class II devices eligible for third party review, excluding special and 3rd party 510(k)s E Rechen, 5/03

  18. Original PMA Milestones:2-cycle Scenario 320 days PMA Received Filing Rev Clock Stops Filing Letter Scientific Review Scientific Review Interactive Review Consults Complete Major Def. Letter Panel Go/NoGo Status Letter Panel Planning Panel Meeting Closeout Review Final Decision

  19. Original PMA Milestones:1-cycle Scenario 180 days PMA Received Filing Review Filing Letter Scientific Review Interactive Review Panel Go/No Go Consults Complete Status Letter Panel Planning Panel Meeting Closeout Review Final Decision

  20. The rest of the story…

  21. Boston Scientific Expands Recall of Troubled Stent Boston Scientific Stent Recall Grows to 96K Units FDA won't expand recall of stents FDA Is Reviewing Reports of Trouble With Taxus Stent FDA Temperature up over Cordis Boston Scientific's Older Stents Draw Scrutiny of FDA Drug-coated stents may face additional FDA scrutiny FDA Advises Physicians of Adverse Events Associated with Cordis Cypher Coronary Stents

  22. Goal: Prioritize Actions on GMP Risks Correlating to Patient Risks GMP Patient Processes Inspection Risk Quality (Patient) Factors RISK  RISK 

  23. Postmarket Questions of Interest • Long Term Safety • Performance in Community Practice • Change in User Setting • Rare/Unexpected Events • Rates of Anticipated Adverse Events • Human Factors Issues – Use Error • Off-Label Use

  24. Achieving Pre/Postmarket Balance

  25. Why Balance Works • Speeds Product to Market by Moving Some Premarket Requirements to Postmarket • Offers Added Assurance to FDA and Advisory Panel • Free Up ODE Staff for Premarket Review • Generates Data for Next Generation • Generates Data for Enhanced Labeling

  26. Postmarket Studies - Present • Ill-Conceived • Not Initiated • Not Completed • Not Tracked • Not Enforced

  27. Postmarket Studies - Future • Better Designs • Standardized Reporting System • Better Tracking • Make Status of Studies Public

  28. Life Sciences Laboratory Awards 2004, GSA Construction Excellence, Projects Over $25 Million 2004, Washington Building Council, Craftsmanship Award (Mechanical / HVAC-Sheet Metal, Mechanical / Plumbing, Mechanical / HVAC-Piping)

  29. Critical Path Projects Being Developed • Establishing a pedigreed and credentialed blood panel that could be used for assessing the sensitivity/specificity of new hepatitis assays • Developing computer models of human physiology that allow testing and soft failure of peripheral vascular stents before animal and human studies are ever considered • Developing a clear regulatory path with consensus from the Obstetrics community for intrapartum fetal diagnostic devices

  30. Critical Path Projects Being Developed • Establishing agreed pathways for the statistical validation of surrogate markers • Working with Medical Specialty Organizations to develop practice guidelines for appropriate monitoring of permanently implanted devices • Obtaining consensus on the extent of neurotoxicity testing for neural tissue contacting materials

  31. Summary • Steady progress towards meeting review performance goals and TPLC strategic goals • Success is achievable but highly resource-intensive • CDRH continues to seek innovative methods and partnerships for evaluating new technology based on sound science in a least burdensome manner • Critical path will further our existing efforts to achieve the right regulatory balance and ensure the safety and effectiveness of medical devices

  32. CDRH Vision – Total Product Life Cycle

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