This presentation summarizes regulations for medical devices in Korea, the United States, and Europe. It discusses classification systems, submission types and requirements. Current topics in US regulation like 510k reform, the medical device tax, FDA-CMS collaboration, and initiatives to promote innovation are also covered. The presentation concludes that while regulations differ somewhat globally, collaboration can help support global trials and submissions, and regulations are evolving to balance innovation and healthcare costs.

1. A PARTNER
IN DRUG AND DEVICE
DEVELOPMENT
EXPERTS
US Medical Device
Regulations and Regulatory
Landscape
PRESENTED BY:
Michael Winegar
Vice President, Regulatory Affairs
Medpace Medical Device

2. Regulatory Agencies

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. 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. 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. FDA: Current Topics and Trends
• 510k reform
• Medical Device
Tax
• CMS (Centers
for Medicare
and Medicaid
Services)
• Audit

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. 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 FDA
2011 Institute of • CDRH found lacking of
Medicine Report human, financial, and
“Medical Devices and
the Public’s Health: The technical resources
FDA 510(k) Clearance • Based on its legislative
Process at 35 Years” foundation, concluded that
510(k) process is flawed,
and should be eliminated!

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. 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 might
PLAN 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. Medical Device Tax
 Part of 2010 Affordable Care
Act
the  2.3% levy on medical device
DEVICE companies
TAX 

Set to go into effect in 2013
Intended to raise $20 billion US
over 10 years

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. FDA Review Trends: 510(k) Decisions
Source: FDA

14. FDA Review Trends: 510(k) AI Requests
Source: FDA

15. FDA Review Trends: PMA Decisions
Source: FDA

16. FDA Review Trends
IDE approvals upon initial review
Fiscal 2000
Fiscal 2009
Source: FDA’s Office of Device Evaluations

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. 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. Regulatory Reform Initiative
Executive Order 13563, issued on
Jan. 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. 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. 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. 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. Medical Device Innovation Initiative
 Prepare for and respond to transformative
innovative technologies and scientific
breakthroughs:
• Enhance CDRH's 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. Conclusions
More similarities than differences in regulations
Positive 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. Thank You!
감사합니다
Michael Winegar
Vice President, Regulatory Affairs
Medpace Medical Device
3787 95th Ave. NE Suite 100
Blaine, MN 55014 USA
Tel: +1.612.234.8491
E-mail: m.winegar@medpace.com