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A PARTNERIN DRUG AND DEVICE    DEVELOPMENT                                      EXPERTS   US Medical DeviceRegulations and...
Regulatory Agencies
Classification of Medical Devices  KOREA       UNITED STATES   EUROPE      RISK PROFILE  Class I        Class I       Clas...
Comparison of Submission Types         KOREA               UNITED STATES                                Class I         Cl...
Comparison of Submission Requirements            KOREA                      UNITED STATES           Class I               ...
FDA: Current Topics and Trends                          • 510k reform                          • Medical Device           ...
510(k) Reform - Background                                    Criticism - overly        “                                ...
510(k) Assessment at 35 years                           Findings:                           • 510(k) process does not     ...
510(k) Reform - Another Perspective   Review of all Class I recalls in 2005 through    2009 (n=118):     • 55% of recalls...
510(k) Reform:Implementation Plan              Consists of 25 proposals to be               implemented in 2011          ...
Medical Device Tax                Part of 2010 Affordable Care                 Act       the      2.3% levy on medical d...
Medical Device Tax   Reaction/Predictions    • US medical devices manufacturers will create/expand      overseas faciliti...
FDA Review Trends: 510(k) Decisions                Source: FDA
FDA Review Trends: 510(k) AI Requests                Source: FDA
FDA Review Trends: PMA Decisions                Source: FDA
FDA Review Trends     IDE approvals upon initial review                   Fiscal 2000                   Fiscal 2009    Sou...
FDA-CMS Parallel Review Program   Pilot program for concurrent review of certain FDA    premarket review submissions for ...
FDA Audits of CROs   FDA Compliance Program 7348.810    • BIORESEARCH MONITORING (BIMO) program       » An FDA audit of S...
Regulatory Reform InitiativeExecutive Order 13563, issued onJan. 18, 2011:   • Ensure that the benefits justify the     co...
Regulatory Reform Initiative HHS issued a Preliminary Plan on May 18, 2011  Review of existing   regulations to help   en...
Medical Device Innovation Initiative                FDA 2010 and 2011 Strategic Plan                 Facilitate the devel...
Medical Device Innovation Initiative   Strengthen the U.S. research infrastructure and    promote high-quality regulatory...
Medical Device Innovation Initiative   Prepare for and respond to transformative    innovative technologies and scientifi...
Conclusions    More similarities than differences in regulationsPositive impact for global clinical trials and submissions...
Thank You! 감사합니다         Michael Winegar Vice President, Regulatory Affairs    Medpace Medical Device    3787 95th Ave. NE...
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Mike Winegar Medpace Medical Device

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Updates for regulatory requirements for Medical Device

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  • BackgroundPublic criticism that 510(k) process allows overly complex devices to get to the US market without premarket review/approvalMetal-on-metal hip implantsKnee implantsVaginal mesh2009 Government Accountability Office Report “FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process”Recommended that all Class III devices be subject to the premarket approval (PMA) process
  • FDA ActivitiesJanuary 2011, FDA announces 510(k) Implementation Plan, consisting of 25 proposals to be implemented in 2011Key proposals include:Eliminate use of multiple predicate devices for a new 510(k)Create a “Class IIb” category that may require additional clinical, manufacturing, and post-market dataNew 510(k) would be required, rather than modification of an existing 510(k), that might affect safety or efficacyMore 510(k)’s will require clinical data, and therefore clinical trialsDraft “510(k) Paradigm Guidance” to be issued by FDA
  • BackgroundPart of 2010 Affordable Care Act2.3% levy on medical device companiesSet to go into effect in 2013Intended to raise $20 billion US over 10 yearsReactionThe Advanced Medical Technology Association (AdvaMed) predicts the tax will force US medical devices manufacturers to create/expand overseas facilitiesThe Centers for Medicare and Medicaid Services (CMS) predicts that costs will be passed on to patients, and therefore, in many cases, back to the government health system!StatusIRS currently writing rules to implement taxAdvaMed, others, pushing for full/partial repeal
  • BackgroundPart of 2010 Affordable Care Act2.3% levy on medical device companiesSet to go into effect in 2013Intended to raise $20 billion US over 10 yearsReactionThe Advanced Medical Technology Association (AdvaMed) predicts the tax will force US medical devices manufacturers to create/expand overseas facilitiesThe Centers for Medicare and Medicaid Services (CMS) predicts that costs will be passed on to patients, and therefore, in many cases, back to the government health system!StatusIRS currently writing rules to implement taxAdvaMed, others, pushing for full/partial repeal
  • Strengthen the U.S. research infrastructure and promote high-quality regulatory science: Establishing a voluntary third-party certification program for U.S. medical device test centers;Creating a publicly-available core curriculum for medical device development and assessment;Leveraging device experience and data collected outside the United States; andAdvancing regulatory science for medical devices through prioritizing scientific research, establishing public-private partnerships, collaborating with other government agencies, and holding public workshops.
  • Transcript of "Mike Winegar Medpace Medical Device"

    1. 1. A PARTNERIN DRUG AND DEVICE DEVELOPMENT EXPERTS US Medical DeviceRegulations and Regulatory Landscape PRESENTED BY: Michael Winegar Vice President, Regulatory Affairs Medpace Medical Device
    2. 2. Regulatory Agencies
    3. 3. Classification of Medical Devices KOREA UNITED STATES EUROPE RISK PROFILE Class I Class I Class I Very Low Risk Class II Class IIa Low Risk Class II Class III Class IIb Medium Risk Class IV Class III Class III High Risk
    4. 4. Comparison of Submission Types KOREA UNITED STATES Class I Class I General Controls Premarket Notification Exempt or 510(k) Class II Class II Premarket Approval General Controls Class III Special Controls Premarket Approval Exempt or 510(k) Class III Class IV General Controls Premarket Approval Premarket Approval
    5. 5. Comparison of Submission Requirements KOREA UNITED STATES Class I Class I Premarket Notification Exempt (usually) Class II Class II/III/IV 510(k) (usually) Premarket Approval Bench, animal, comparative Technical File Review data 4-6 months 3 month review Class III Safety/Efficacy Review + Type PMA (usually) Testing + Human clinical data 6-10 months 6 month review
    6. 6. FDA: Current Topics and Trends • 510k reform • Medical Device Tax • CMS (Centers for Medicare and Medicaid Services) • Audit
    7. 7. 510(k) Reform - Background Criticism - overly “  complex devices get to the US market FDA should take steps without premarket to ensure that high- approval (PMA) risk Device types are » Metal-on-metal hip approved through implants the most stringent » Knee implants premarket review process.” » Vaginal mesh  Recommendation - 2009 Government Accountability Office Report all Class III devices be subject to the PMA process
    8. 8. 510(k) Assessment at 35 years Findings: • 510(k) process does not assess safety or efficacy • 510(k) process use of “predicate devices” sets binding precedent on FDA2011 Institute of • CDRH found lacking ofMedicine Report human, financial, and“Medical Devices andthe Public’s Health: The technical resourcesFDA 510(k) Clearance • Based on its legislativeProcess at 35 Years” foundation, concluded that 510(k) process is flawed, and should be eliminated!
    9. 9. 510(k) Reform - Another Perspective Review of all Class I recalls in 2005 through 2009 (n=118): • 55% of recalls relate to post-market issues • 99.78% of 510(k) submissions do not result in a Class I recall due to premarket issues Conclusion: additional human studies of 510(k) devices will not have a significant impact on Class I recalls Source: 2010 Ralph Hall, University of Minnesota Law School, presentation entitled “Using Recall Data To Assess The 510(k) Process”
    10. 10. 510(k) Reform:Implementation Plan  Consists of 25 proposals to be implemented in 2011  Key proposals include: • Eliminate use of multiple predicate devices the Create a “Class IIb” category FDA • New 510(k) would be required, rather than modification of an existing 510(k), that mightPLAN affect safety or efficacy • More 510(k)’s will require clinical data, and therefore clinical trials  Draft “510(k) Paradigm Guidance” to be issued by FDA
    11. 11. Medical Device Tax  Part of 2010 Affordable Care Act the  2.3% levy on medical deviceDEVICE companies TAX   Set to go into effect in 2013 Intended to raise $20 billion US over 10 years
    12. 12. Medical Device Tax Reaction/Predictions • US medical devices manufacturers will create/expand overseas facilities (The Advanced Medical Technology Association (AdvaMed) ) • Costs will be passed on to patients, and therefore, in many cases, back to the government health system (The Centers for Medicare and Medicaid Services (CMS)) Status • IRS currently writing rules to implement tax • AdvaMed, others, pushing for full/partial repeal
    13. 13. FDA Review Trends: 510(k) Decisions Source: FDA
    14. 14. FDA Review Trends: 510(k) AI Requests Source: FDA
    15. 15. FDA Review Trends: PMA Decisions Source: FDA
    16. 16. FDA Review Trends IDE approvals upon initial review Fiscal 2000 Fiscal 2009 Source: FDA’s Office of Device Evaluations
    17. 17. FDA-CMS Parallel Review Program Pilot program for concurrent review of certain FDA premarket review submissions for medical devices and CMS national coverage determinations • Goal: reduce the interval between FDA approval and CMS coverage to bring new technologies to patients quicker During this pilot phase, up to five “new technology” devices/year will be eligible. Must meet one of these criteria: • Approved IDE • Would/will require a PMA • Fall within the scope of a current Medicare benefit category
    18. 18. FDA Audits of CROs FDA Compliance Program 7348.810 • BIORESEARCH MONITORING (BIMO) program » An FDA audit of Sponsor and select clinical study sites, to ensure compliance with relevant regulations • Revised March 2011 to include CROs and Monitors » FDA medical device regulations (21 CFR Part 812) do not define or delineate responsibilities for CROs • FDA can, and has begun to, audit CROs independent of a specific IDE/PMA activity » Findings of CRO audit may lead FDA to conduct Sponsor and/or clinical study site BIMO audits
    19. 19. Regulatory Reform InitiativeExecutive Order 13563, issued onJan. 18, 2011: • Ensure that the benefits justify the costs and to select the least- burdensome alternatives • Increased public participation and an open exchange • Harmonize, simplify, and coordinate rules • Consider flexible approaches that reduce burdens and maintain freedom of choice for the public
    20. 20. Regulatory Reform Initiative HHS issued a Preliminary Plan on May 18, 2011  Review of existing regulations to help ensure that FDA’s regulatory program is more effective and less burdensome in achieving its regulatory objectives
    21. 21. Medical Device Innovation Initiative FDA 2010 and 2011 Strategic Plan  Facilitate the development and regulatory evaluation of innovative medical devices: • Establish the Innovation Pathway - a priority review program for pioneering medical devices • Streamline the de novo pathway
    22. 22. Medical Device Innovation Initiative Strengthen the U.S. research infrastructure and promote high-quality regulatory science: • Voluntary third-party certification program for test centers • Public core curriculum for medical device development and assessment • Leverage device experience and data collected outside the US • Prioritize scientific research, establish public-private partnerships, collaborate with other government agencies, and hold public workshops
    23. 23. Medical Device Innovation Initiative Prepare for and respond to transformative innovative technologies and scientific breakthroughs: • Enhance CDRHs current horizon scanning process » Adopt emerging horizon scanning methods » Seek public input to identify important and innovative medical device technologies » Periodically report horizon scanning findings to the public • Develop Networks of Experts to assist in addressing scientific questions about unfamiliar emerging technologies
    24. 24. Conclusions More similarities than differences in regulationsPositive impact for global clinical trials and submissions Regulations are under increased scrutiny Public, congressional, industry pressures The cost of healthcare remains an issue Balancing the need for and requirements of innovation Indications of positive change on the horizon Signals of changes to come from FDA
    25. 25. Thank You! 감사합니다 Michael Winegar Vice President, Regulatory Affairs Medpace Medical Device 3787 95th Ave. NE Suite 100 Blaine, MN 55014 USA Tel: +1.612.234.8491E-mail: m.winegar@medpace.com
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