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CDRH Update Facilitating Medical Device Innovation and Technology

Center for Devices and Radiological Health. C. D. R. H. CDRH Update Facilitating Medical Device Innovation and Technology. Dan Schultz, MD Director, Center for Devices and Radiological Health Food and Drug Administration Sixth Annual National Forum on Biomedical Imaging in Oncology

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CDRH Update Facilitating Medical Device Innovation and Technology

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  1. Center for Devices and Radiological Health C D R H CDRH UpdateFacilitating Medical Device Innovation and Technology Dan Schultz, MD Director, Center for Devices and Radiological Health Food and Drug Administration Sixth Annual National Forum on Biomedical Imaging in Oncology Bethesda, MD April 7, 2005

  2. What is a Device?

  3. A Computer That Helps You Hear

  4. Miniaturized DevicesElectrical Stimulators Pacemakers

  5. Personal Programming Communicator Implantable Sc pump Insulin Delivery Catheter Intravascular Glucose sensor “Smart” Drug Delivery Devices Information-Rich Therapeutics

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

  7. Intelligent DevicesStent as a Radiofrequency Identifier Preclinical Model of Self Monitoring Stent • Applications: detect restenosis • Measure blood pressure continuously Yogesh Gianchandani and his team at the University of Michigan

  8. Minimally Invasive DevicesImage (MRI) Guided Treatment (HiFU) Information Rich Therapeutics Diagnostics and Therapeutic Device Uses magnetic resonance image (MRI) guided focused ultrasound to target and destroy non-cancerous uterine fibroids

  9. Medical Imaging Devices Image Analysis Software Aids in the detection of lung nodules Digital Mammography Produces images using X-rays instead of film

  10. Left Ventricular Assist Device for Pediatric Use Stair-Climbing Wheelchair Technology for Special Populations

  11. Technology Designed for Home Use A Defibrillator for the Home Home Testing for HIV

  12. Point of Care Diagnosis and Therapy Devices • Enhancement of point of care testing • Enhanced portability of increasingly complex laboratory analysis • Example: A portable test has been approved by CBER for HIV • CDRH expects other high risk technologies to follow

  13. Biological Medical DevicesGenomics Impact on Therapeutic Products • New knowledge about disease • Animal models • Pharmacogenomics: • Identify responders • Understand toxicity • Clinical diagnosis • Clinical treatment monitoring Personalized Medicine

  14. Biological Medical DevicesBiotechnology Revolution Microarray Technology • Providing insight into patient factors allowing for personalized medicine • Amplichip Personalized Medicine

  15. Technology We Hope We Never Need Bioterrorism Diagnostic Testing Bioterrorism Diagnostic Testing • Testing for biological warfare agents including microbes and toxic chemicals • Biosensor detectors • Nucleic acid amplification QuickELISA Anthrax-Pa Kit The first rapid serum antibody test for anthrax Challenge: Studies using real clinical samples may not be possible so flexible regulatory and scientific alternatives are essential

  16. Technology and Innovation What are the challenges today for bringing new medical technology to market? • Accelerated Pace of Technology and Innovation • Complexity of New Technology

  17. The Accelerating Pace of Technology and InnovationAdvances in Medical Imaging Traditional Lateral Skull Film

  18. The Accelerating Pace of Technology and InnovationAdvances in Medical Imaging 41 CT slices

  19. The Accelerating Pace of Technology and InnovationAdvances in Medical Imaging 3-D CT Imaging

  20. The Accelerating Pace of Technology and InnovationAdvances in Medical Imaging

  21. Medical Device Industry Growth Number of Manufacturers by Year Dun & Bradstreet Medical Device Firm Data

  22. Sales Volume Growth (Billions of Dollars) Note: No economic adjustment to dollar value

  23. The Complexity of New Technologies • Devices are getting smaller • Miniaturization, New Materials, Nanotechnology • Devices are getting smarter and are providing more information • Intelligent Devices • Biotechnology Revolution • Personalized Medicine • Combination Products • Information-Rich Therapeutics

  24. The Complexity of New Technologies • Devices are becoming more convenient for the patient • Home Use • Minimally Invasive • Point of Care Diagnostics • Devices are responding to heighten homeland security • Bioterrorism-Related Devices • Devices are meeting the needs for special populations

  25. Technology and InnovationFDA Role Establish reasonable assurance of the safety and effectiveness of medical devices marketed in the U.S.

  26. Technology and InnovationCDRH Challenges • Effectively Managing a Changing Workload • Increasing number of expedited submissions, combinations products and submissions with clinical data • New Kinds of Scientific Expertise • Meeting MDUFMA Commitments • Performance goals • Third-party inspections • Establishing a Premarket/Postmarket Balance • Greater degree of scrutiny

  27. Medical Device Program CDRH: Types and Numbers of Submissions Received * The majority of PMAs and 510(k) applications are subject to fees. Exceptions include small business and pediatric applications.

  28. These are the issues that we face everyday… Implementation of the Medical Device User Fee and Modernization Act of 2002… … a complex and comprehensive set of review goals, becoming more aggressive each year.

  29. The number of expeditedsubmissions is growing…. … shortening timeframes and bringing increasingly complex scientific questions… The number of combination products is growing… … necessitating new kinds of technical expertise and new regulatory paradigms

  30. The complexity and need for clinical data is growing… Embolic protection devices Daily wear contact lenses Vascular anastomosis devices for CABG CPAP devices for apnea … requiring more in-depth review, including occasional Panel input Barbed sutures Glaucoma shunts Image-guided bronchoscopes

  31. BioterrorismEmergency Measures • Emergency Preparedness - Medical device emergency shortages database • Bioterrorism Diagnostics and Testing - QuickELISA Anthrax-Pa Kit, the first rapid serum antibody test for anthrax • ASTM F2401-04 - “Standard Practice for Security Checkpoint Metal Detector Screening of Persons with Medical Devices”

  32. Meeting Technology Innovation Challenges

  33. Meeting the Challenges of Technology and Innovation Strategic planning helps us achieve our goals and establish a vision for the future • Meeting MDUFMA Goals • Strengthening our workforce for the 21st century • Enhancing our knowledge management • Achieving a better pre/postmarket regulatory balance

  34. CDRH FY 05

  35. Priority Hiring FY 03 and FY 04 Hires (by Specialty)

  36. Professional Development • Develop training programs • Provide professional and career development opportunities • Science Leadership Education Program (SLEP) • Basic Science Education Program (BSEP) • Develop competency models • Science • Management • Business

  37. External Expertise • Premarket reviews and consults • Human factors issues • Analysis of device failure modes • Standards and guidance development • Statistical analyses Medical Device Fellowship Program (MDFP) Since its inception, MDFP has sponsored over 100 fellows in the program www.fda.gov/cdrh/mdfp

  38. Guidance Development • Create a list of high priority guidances • Establish performance goals • Develop tracking mechanisms • Engage industry stakeholders in the early stages of guidance development

  39. Standards Development • Recognition – to have significant influence throughout the world • Participation – to work with national and international committees CDRH Standards Participation • 38 development organizations • 238 Liaison Reps: 220 National Committees and 128 International Committees • 538 Standards Activities: 365 National and 173 Other Activities • Utilization • Standards utilization in recent device applications - 55%

  40. Global Harmonization Task Force Mission: Encourage the convergence of medical device regulatory practices worldwide where possible, while ensuring the safety, effectiveness, and quality of medical devices. • Develop guidance documents on basic regulatory practices • Continue participating in GHTF study groups • Study Group 1: regulatory and premarket requirements • Study Group 2: postmarket vigilance • Study Group 3: quality systems • Study Group 4: regulatory auditing of quality systems • NEW Study Group 5: Clinical Evidence

  41. Quality Systems for Application Review • Focus on selected cross-cutting areas • e.g., biocompatibility • Use retrospective (post-decision) peer assessments • Assemble quality assessment teams • Continue with pilot program

  42. Premarket Review Modernization Postmarket Medical Device Reporting (eMDR) ODE and OC Tracking Systems Electronic Registration and Listing eConsult Image2000 Turbo 510(k) IT Initiatives

  43. IT Initiatives Image2000 • Scan outgoing 513g and reduce backlog • Decrease original PMA scanning times • Scanning 510(k) in real time • Electronic copies to eliminate need for scanning

  44. IT Initiatives Turbo 510(k) • Continue pilot eSubmission with industry volunteers • Develop eLoader tool for reviewers, allowing copy and paste from eSubmission into external applications • Develop eReview tool, a standard 510(k) review template

  45. Criteria For Rating Projects Regulatory need: PMA and IDE activity Scientific gaps and technical competence: leading edge products Public health impact: mortality, morbidity, quality of life FY 05 Goals Continue using prioritization model FY 04 Update 73 projects (14 programs) Approximately 90 TRC members participated Approximately 145 OSEL staff are involved 72 TRC members from CDRH, and the rest from CDER, CBER, EPA, NIST, etc. Research Prioritization

  46. Basic Research Prototype Design or Discovery Preclinical Development Clinical Development FDA Filing/ Approval & Launch Preparation Translational Research Critical Path Research Critical Path Research • Leverages basic science knowledge • Leverages cumulative research experiences Does not compromise safety and effectiveness evaluations

  47. Critical Path Research Update • We have reviewed and compiled all of the comments received on the public docket • Critical Path Public Docket Solicited thoughts on areas benefit from research and development of critical path evaluative tools • We are nearing completion the National Critical Paths Opportunities List

  48. Organizational Scorecards Scorecards help manage organizational performance in CDRH strategic areas FY 05 Goals • Update Center scorecards, includes implementing Quality review Assessment metrics • Develop a pilot automated scorecard tool

  49. Project Management Plans FY 05 Goals Effectively manage long term projects and new initiatives • Project milestones • Resource requirements • Quarterly reports

  50. Life Sciences building opened Dec. 2003 Shared between CDRH and CDER Considerable progress on the CDER Office building and the Award-winning Shared Use building Engineering and Physics building 100% design Expected occupancy Spring 2006 Improving InfrastructureWhite Oak

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