"Medical Device Regulation, A Delicate Balance, An Evolving Process: What does it mean to you?"


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Dr. Daniel Schultz, Senior Vice President at Greenleaf Health LLC

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"Medical Device Regulation, A Delicate Balance, An Evolving Process: What does it mean to you?"

  1. 1. Medical Device Regulation, A Delicate Balance, An Evolving Process: What does it mean to you? Medtech Conference Rochester, NY September 24-25, 2012 Dan Schultz, MDSenior Vice President, Medical Devices & Combination Products
  2. 2. Regulation: A Delicate Balance
  3. 3. Dilemmas Mandate Patientto protect the VS. autonomy public health Product Product safety and VS. availabilityeffectiveness 3
  4. 4. “Total Product Life Cycle” Vision Efficient, Efficient, Effective, and Predictable and Predictable Product Development Development Ensuring Ensuring the Safety of Enabling Enabling Marketed Access to Access toMedical DevicesMedical Devices Innovation
  5. 5. Change is InevitableTemple report Reengineering Strategic Planning Post-market Transformation510(k) Reform/ Innovation Initiative
  6. 6. ChangeTo what end?How much?How fast?What will it cost?What will it accomplish?
  7. 7. Increasing Device Complexity Internal CDRH Consults (FY2010 vs. FY2008)PercentIncrease
  8. 8. CDRH’s Legislative Mandates1976 Medical Device Amendment of 19761988 Clinical Laboratory Improvement Amendments (CLIA)1990 Safe Medical Devices Act (SMDA)1992 Mammography Quality Standards Act (MQSA)1992 Medical Device Amendments1997 Food & Drug Administration Modernization Act (FDAMA)2002 Medical Device User Fee and Modernization Act (MDUFMA)2005 Medical Device User Fee Stabilization Act (MDUFSA)2007 Food and Drug Administration Amendments Act of 2007 (FDAAA)2012 FDA Safety and Innovation Act
  9. 9. Recent Changes at CDRH/FDA• Personnel• Premarket: 510(k), IDE, PMA• Enforcement & Compliance• Policy Guidance• FDA/ CDRH Initiatives
  10. 10. CENTER FOR DEVICES & RADIOLOGICAL HEALTH (CDRH) Regulatory & Scientific Senior Staff Office of Ombudsman Regulations & Policy OFFICE OF CENTER DIRECTOR David Buckles Nancy Stade Jeffrey Shuren, MD, JD Deputy Director for Science Sr. Associate Director William Maisel, MD Lillian Gill Office of SurveillanceOffice of Compliance Office of Device Evaluation & Biometrics Steve Silverman Christy Foreman Susan Gardner 510(k) Program Staff Marjorie Shulman Office of Science and Office of In Vitro Diagnostic Engineering Laboratories Device Evaluation & Safety Steve Pollack Alberto Guiterrez Leadership changes since 2009
  11. 11. Classification and 510(k) 21 CFR 870.1875 StethoscopePro Code: LDE Pro Code: DQD Pro Code: DQDManual Stethoscope Electronic Stethoscope Electronic StethoscopeClass 1 510(k) Exempt Class 2 510(k) Required Class 2 510(k) Required Pro Code: OCR Lung Sound Monitor Class 2 510(k) Required
  12. 12. What is Substantial Equivalence?“The term ‘substantially equivalent’ is not intended to be so narrow as to referonly to devices that are identical to marketed devices nor so broad as to refer todevices which are intended to be used for the same purposes as marketedproducts. The committee believes that the term should be construed narrowlywhere necessary to assure the safety and effectiveness of a device but notnarrowly where differences between a new device and a marketed device do notrelate to safety and effectiveness.” 1976 Congressional Record
  13. 13. Reforming the 510(k) PlanFDA’S Two Pronged Approach:External Evaluation• Institute of Medicine (IOM) - independent evaluation of the 510(k) programCDRH Evaluation• 510(k) Working Group - evaluate how well the 510(k) program was meeting its two public health goals and explore actions CDRH should take to strengthen it• Task Force on the Utilization of Science in Regulatory Decision Making - make recommendations on how the Center can quickly incorporate new science — including evolving information, novel technologies, and new scientific methods — into its decision making in as predictable a manner as is practical
  14. 14. Reports & Public Documents 510(k) Internal Evaluations hthttp://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM220784.pdf 510(k) IOM Report http://www.iom.edu/Activities/PublicHealth/510KProcess.aspx 510(k) Science Report http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM220783.pdf CDRH 510(k) Action Planhttp://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm239448.htm
  15. 15. Update Class III 510(k)s/ 515(b)Approximately 170 preamendment class III device typesSMDA 1990 required FDA to completeGAO Report Jan. 2009 criticized FDA for not completingApproximately 25 devices types remainSeveral panels meetings and proposals issuedDecision on proposals for final 25 should be complete by 12/12Final actions???
  16. 16. IDE A key piece of the R&D process For many devices, first contact with CDRH Patient must be protected, however Approvability cannot be guaranteed Timeliness and flexibility are essential
  17. 17. PMA Highest risk/reward Generally less certainty, more questions Benefit/Risk Guidance should help but, Cannot substitute for good judgment and, Appropriate pre/post-market balance
  18. 18. The IOMThe Question: Too broad?The “Evidence”: “Expert testimony”The Method: No review of submissionsThe Recommendation: Replace 510(k)/ with what?Unresolved: Does SE equal S&E?, are other systems better?
  19. 19. The Debate Goes OnPerspectivePatient Access to Medical Devices — A Comparison of U.S. and European Review Processes Saptarshi Basu, M.P.A., and John C. Hassenplug, M.Sc.August 1, 2012 (10.1056/NEJMp1204170)SOURCE INFORMATION From the Office of Planning, Office of the Commissioner, Food and Drug Administration, White Oak, MD.
  20. 20. Enforcement & Compliance IncreaseCommissioners Enforcement Initiative• Enhanced regulatory oversight and timely Agency follow-up action including aggressive Enforcement Action, when appropriate• Coordinated risk review regarding device performance• Increased accountability to improve Warning Letter and recall processing times• Additional inspection resources
  21. 21. CDRH Enforcement InitiativeIncreased attention to compliance and enforcement at CDRH• New Director of Compliance Office, Steve Silverman• Enhanced screening of imports• Global data sharing• 3rd party (public and private) inspections and oversight• Emphasis on business benefits to compliance
  22. 22. FDA Warning Letter IncreaseFDA LETTERS ISSUED 2005 - 2010
  23. 23. CDRH Warning Letter Increase CDRH LETTERS ISSUED 2002 - 2010
  24. 24. CDRH Innovation Initiative Innovation PathwayEligible Devices Must be Truly Pioneering Medical Devices and Meet One of the Following Criteria:1. significantly improve upon currently available treatments or diagnostics for life- threatening or irreversibly debilitating diseases or conditions;2. treat or diagnose a life-threatening or irreversibly debilitating disease or condition for which no approved or cleared alternative treatment or means of diagnosis exists;3. address an unmet public health need as identified by the Council on Medical Device Innovation; or4. address an issue relevant to national security
  25. 25. So what does it all mean?There is clearly a desire at FDA to demonstrate changeThe fallout from all of these initiatives even prior to formal adoption of new policies is profoundWhere these changes will ultimately net out?Will that delicate balance be restored?What will be the ultimate effect on public health?
  26. 26. So what can you do…Understand the new realityGet involved in the processChoose projects carefullyWatch for curveballsUtilize the global marketAnticipate further changes Don’t Give Up!
  27. 27. 27 Conclusion 27THANK YOU! 27