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.

2. Our Story….
Who is OSMA?
Our Evolution
Fostering Collaborative
Partnerships in the Orthopedic
Industry

4. 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

5. 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

6. Collaboration Opportunities
Industry
Peers
FDA
EU Notified
Bodies
Global
Regulators
Professional
Societies
(AAOS)

8. 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

14. 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…

15. 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.

16. 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.

17. 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

18. 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

19. 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

20. 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

21. Why Harmonize?
• FDA ISO 13485:2016 harmonization
• MDSRP – Med Dev Single Review Program
• MDSAP – Med Dev Single Audit Program
Global Harmonization

22. • MDSAP Participating Manufacturing Sites
Global Harmonization
OSMA Spring 2019 Session: CDRH and Orthopedic Devices Updates

23. 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

24. • 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

25. • 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

26. • Partnership with Regulators
Future Opportunities
Roundtable with FDA
Townhall with Notified Bodies

27. • Partnership with Regulators
Future Opportunities
OSMA Regulatory Performance Metrics

28. 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

29. 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

30. 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

31. Be part of our journey…