Medical Device Regulation is a delicate balance between protecting public health and enabling access to innovation. The FDA is undergoing changes to improve the regulatory process through initiatives like 510(k) reform and the Innovation Pathway. This includes increasing enforcement, updating guidance, and incorporating new science more predictably. The effects of these changes on public health and the industry are still unfolding.

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, MD
Senior Vice President, Medical Devices & Combination Products

2. Regulation: A Delicate Balance

3. Dilemmas
Mandate
Patient
to protect the VS.
autonomy
public health
Product
Product
safety and VS. availability
effectiveness
3

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 to
Medical Devices
Medical Devices Innovation

5. Change is Inevitable
Temple report
 Reengineering
 Strategic Planning
 Post-market Transformation
510(k) Reform/ Innovation Initiative

6. Change
To what end?
How much?
How fast?
What will it cost?
What will it accomplish?

7. Increasing Device Complexity
Internal CDRH Consults (FY2010 vs. FY2008)
Percent
Increase

8. CDRH’s Legislative Mandates
1976 Medical Device Amendment of 1976
1988 Clinical Laboratory Improvement Amendments (CLIA)
1990 Safe Medical Devices Act (SMDA)
1992 Mammography Quality Standards Act (MQSA)
1992 Medical Device Amendments
1997 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. Recent Changes at CDRH/FDA
• Personnel
• Premarket: 510(k), IDE, PMA
• Enforcement & Compliance
• Policy Guidance
• FDA/ CDRH Initiatives

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 Surveillance
Office 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. Classification and 510(k)
21 CFR 870.1875
Stethoscope
Pro Code: LDE Pro Code: DQD
Pro Code: DQD
Manual Stethoscope Electronic Stethoscope
Electronic Stethoscope
Class 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. What is Substantial Equivalence?
“The term ‘substantially equivalent’ is not intended to be so narrow as to refer
only to devices that are identical to marketed devices nor so broad as to refer to
devices which are intended to be used for the same purposes as marketed
products. The committee believes that the term should be construed narrowly
where necessary to assure the safety and effectiveness of a device but not
narrowly where differences between a new device and a marketed device do not
relate to safety and effectiveness.”
1976 Congressional Record

13. Reforming the 510(k) Plan
FDA’S Two Pronged Approach:
External Evaluation
• Institute of Medicine (IOM) - independent evaluation of the 510(k) program
CDRH 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. 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 Plan
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm239448.htm

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. 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. 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. 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. 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. Enforcement & Compliance Increase
Commissioner's 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. CDRH Enforcement Initiative
Increased 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. FDA Warning Letter Increase
FDA LETTERS ISSUED 2005 - 2010

23. CDRH Warning Letter Increase
CDRH LETTERS ISSUED 2002 - 2010

24. CDRH Innovation Initiative
Innovation Pathway
Eligible 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; or
4. address an issue relevant to national security

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. 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!

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Conclusion
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THANK YOU!
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