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OSMA: Orthopedic Industry's Top Regulatory Challenges and Opportunities

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The Orthopaedic Surgical Manufacturers Association, a collective voice of orthopedic device companies that influences the decision of worldwide regulatory agencies and standards bodies, will highlight the main regulatory changes impacting the industry. This session is for any orthopedic professional who wants a forecast of regulatory pressures and seeks direction on how to shape change. Attendees will learn how FDA, European agencies and IMDRF are approaching harmonization and alignment of standards, regulations and guidance. OSMA Members will provide future trends and opportunities afforded via FDA’s National Evaluation System for Health Technology (NEST), facilitation of innovation through partnerships and global harmonization of regulatory submissions and facility assessments.

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OSMA: Orthopedic Industry's Top Regulatory Challenges and Opportunities

  1. 1. Our Story…. Who is OSMA? Our Evolution Fostering Collaborative Partnerships in the Orthopedic Industry
  2. 2. 1 2 3 4 5 6 7 8 1995-AAOS Orthopaedic Device Forum Formed 9The road we’ve traveled… ….early beginnings…..OSMA formed in 1954 ASTM F-04 Committee formed in 1962 Early 1970s-Focus on development of orthopedic standards 1970s-Screw head slots/screw driver incompatibility issue 1970s-Total hip replacement gains in popularity in the US 1970s-FDA orthopedic advisory panel formed to classify devices 1970s-GMPs drafted for orthopedic devices May 28, 1976-Medical device amendments to FDA FD&C Act
  3. 3. Our Journey Since… Regulatory Processes Impacting the Orthopedic Community and Patients Proposed Guidance and Rulemaking Standards Reclassification Petitions Education of Membership Building Strong Partnerships and Engagement with Global Regulators
  4. 4. Collaboration Opportunities Industry Peers FDA EU Notified Bodies Global Regulators Professional Societies (AAOS)
  5. 5. 2019 SPRING MEETING ∙ APRIL 25TH & 26TH ∙ ANNAPOLIS, MARYLAND Affiliation Speaker Agenda Topic FDA CAPT Raquel Peat, PhD, MPH, USPHS Orthopedic Devices Update FDA Melissa Hall/ Ronald Jean, PhD Anterior/Posterior Spinal Devices Update FDA Kate Kavlock, PhD New Guidance Documents TABLE TOPIC DISCUSSIONS FDA FDA Mark Melkerson Jonathan Peck 510(k) Bundling Considerations Spinal Standards - Needs and Revisions FDA Constance Soves, PhD Classification of Orthopedic Instrument Accessories FDA Jonathan Peck Orthopedic Rapid Comparative Analysis (ORCA) FDA Edward Margerrison, PhD (OSEL) Cross Cutting Biocompatibility Updates FDA Terry Woods, PhD (OSEL) Minimizing Force and Torque Testing for MRI Safety Assessments FDA Shumaya Ali 2017 Risk-Based Inspections Update FDA Vesa Vuniqi Top Orthopedic Recalls FDA Marjorie Shulman 510(k) Program Updates
  6. 6. Global Regulatory Changes 2019 and beyond… The Medical Device industry faces an ever changing environment having experienced significant changes with increasing requirements associated with manufacturing, commercialization, and postmarket monitoring • Legislation • Regulations • Guidance Documents • Standards Industry representation through organizations such as OSMA provide medical device companies the opportunity to better understand, align, and shape the regulatory environment through collaboration with various rule- makers and regulators. You’re not in this alone…
  7. 7. Opportunities for Partnerships and Collaboration Regulators’ approaches toward harmonization and alignment of standards, regulations and guidance are enhanced through industry participation OSMA offers a shared forum to discuss concerns and experiences with a range of companies, large and small.
  8. 8. EU MDR and Brexit Key challenges with the decentralized structure in Europe • Involves multiple stages and involved entities within the regulatory decision-making process • Notified Bodies (NB) certified to MDR • Authorities and parliament • Technical Documentation will contain significant increases in information for approvals • Increases in requirements not only affect legal manufacturers, but also impacts critical components suppliers • Lack of a common Masterfile system in the decentralized structure for the EU • Concerns regarding IP protection of trade secret or proprietary information • Organizations such as OSMA are impactful, enabling a safe environment for focused, constructive conversation with regulators and notified bodies to assist in refinement and harmonization efforts.
  9. 9. International Medical Device Regulators Forum IMDRF activities – Country regulators’ representatives and industry group collaboration provide harmonization and alignment resulting in Policies, Guidance and Proposals. OSMA members have had access to many different regulators in an educational and interactive environment to discuss topics ranging from emerging regulations, performance metrics, collaboration on pipeline guidances, and classification petitions and positions. MDSAP The Medical Device Single Audit Program transitioned from “pilot” to a more common approach to audits in 2018 • Countries currently participating in MDSAP include Australia, Brazil, Canada, Japan, and the United States • Health Canada began requiring ISO 13485:2016 and MDSAP by January 1, 2019 • CDRH and ORA are planning to move from 21CFR820 Quality System Regulation (QSR) to ISO 13485 via Proposed Rule in 2020
  10. 10. International Medical Device Regulators Forum Spotlight on… ToC Regulated Product Submission - Assembly and Technical Guide for IMDRF Table of Contents (ToC) Submissions Proposed document was released in March 2015, and was intended to provide an internationally harmonized format for use when filing medical device submissions to regulatory authorities for market authorization. • CDRH piloted ToC for 510(k) & PMA submissions on September 2015 • Health Canada adopted ToC on April 2019 • Supports the transition to electronic submissions for various countries
  11. 11. Challenges or Opportunities? • Variety of regulatory review processes • Increasing clinical evidence requirements resulting in more extensive post-market surveillance • Continued emergence of new regulations for countries currently without or limited medical device controls • Continued or increased enforcement of new country-specific labeling requirements
  12. 12. Future Trends • Global Harmonization Possibilities • NEST – Real World Evidence for Innovation • ORCA - FDA Database of Mechanical Data Future Opportunities • Partnerships with Regulators Future Trends and Opportunities
  13. 13. Why Harmonize? • FDA ISO 13485:2016 harmonization • MDSRP – Med Dev Single Review Program • MDSAP – Med Dev Single Audit Program Global Harmonization
  14. 14. • MDSAP Participating Manufacturing Sites Global Harmonization OSMA Spring 2019 Session: CDRH and Orthopedic Devices Updates
  15. 15. Shared data capture - +10 Data partners - 150 hospitals - +1000 outpatient clinics - Totaling +470m patient records Safety - Real World Evidence (RWE) for Post Market surveillance/coverage Performance - RWE for pre-market applications, label expansions, post-market approvals NEST = National Evaluation System for health Technology
  16. 16. • Databases that contain design and mechanical testing data from cleared 510(k)s to allow for fast identification of predicates • Allows for larger scale analysis of product areas and publication of deidentified aggregated data in the literature or guidance documents ORCA = Orthopedic Rapid Comparative Analysis Jonathan Peck, FDA – Participating in a roundtable discussion at OSMA • Goals • Transparency in 510(k) reviews • Reduce time searching for predicates and overall total review time • Reduce some of the need for side by side testing • Issue fewer deficiencies based on mechanical performance, or more definitive deficiencies
  17. 17. • 2 Publications • Descriptive and test records from almost 800 submissions • Spine Focused • Cages • Plates • Pedicle Screws • Fracture Fixation • Is the future FDA Safety and Performance Specifications? ORCA: Progress
  18. 18. • Partnership with Regulators Future Opportunities Roundtable with FDA Townhall with Notified Bodies
  19. 19. • Partnership with Regulators Future Opportunities OSMA Regulatory Performance Metrics
  20. 20. 1. Regulatory review process improvements (MDUFA IV/ 21st Century Cures) 2. FDA TPLC reorganization a. New reviewers, increased depth of reviews and compressed timelines for AI responses 3. Leveraging RWE in regulatory decision making 4. Pathway to reclassify orthopedic instrument accessories 5. Future FDA re-vamp of 510(k) review process a. Encourage De Novo with special controls b. Limit scope of predicate devices to newer technology Summary: US Opportunities
  21. 21. 1. Continued focus on EU MDR compliance 2. Increased clinical evidence requirements a. More extensive PMS 3. Emerging new regulations for countries with no/limited medical device regulations 4. Enforcement of new country-specific labeling requirements 5. Brexit Summary: EMEA Opportunities
  22. 22. 1. China- a. More flexible clinical evidence requirements b. Expedited review for novel devices c. Simplified device type testing d. Increased AE reporting and PMS 2. Australia- a. Patient implant cards and leaflets; e-IFUs for professional use devices b. Restricted reliance on equivalent comparator devices c. Mutual recognition from other HAs (US, Canada, Japan, MDSAP) 3. India- a. Device-specific mandatory standards b. Proposed company compensation for AEs 4. Japan a. MRI compatibility labeling and data Summary: ASPAC Opportunities
  23. 23. Be part of our journey…

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