Post on 13-Dec-2014
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Medical Device Regulation, A Delicate Balance, An Evolving Process:
What does it mean to you?
Medtech ConferenceRochester, NY
September 24-25, 2012Dan Schultz, MD
Senior Vice President, Medical Devices & Combination Products
Regulation: A Delicate Balance
3
Dilemmas
Mandate to protect the public health
Mandate to protect the public health
Patient autonomyPatient
autonomy
Product safety and
effectiveness
Product safety and
effectiveness
Product availabilityProduct
availability
VS.VS.
VS.VS.
“Total Product Life Cycle” Vision
Enabling Enabling Access to Access to InnovationInnovation
Enabling Enabling Access to Access to InnovationInnovation
Efficient, Efficient, Effective, Effective,
and Predictable and Predictable Product Product
DevelopmentDevelopment
Efficient, Efficient, Effective, Effective,
and Predictable and Predictable Product Product
DevelopmentDevelopment
Ensuring Ensuring the Safety ofthe Safety of Marketed Marketed
Medical DevicesMedical Devices
Ensuring Ensuring the Safety ofthe Safety of Marketed Marketed
Medical DevicesMedical Devices
Change is Inevitable
Temple report
Reengineering
Strategic Planning
Post-market Transformation
510(k) Reform/ Innovation Initiative
Change
To what end?
How much?
How fast?
What will it cost?
What will it accomplish?
Increasing Device Complexity
Internal CDRH Consults (FY2010 vs. FY2008)
PercentIncrease
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
Recent Changes at CDRH/FDA
• Personnel
• Premarket: 510(k), IDE, PMA
• Enforcement & Compliance
• Policy Guidance
• FDA/ CDRH Initiatives
CENTER FOR DEVICES & RADIOLOGICAL HEALTH (CDRH)Regulatory & Scientific Senior Staff
Leadership changes since 2009
OFFICE OF CENTER DIRECTORJeffrey Shuren, MD, JD
Deputy Director for ScienceWilliam Maisel, MD
Office of ComplianceSteve Silverman
Office of Device EvaluationChristy Foreman
Office of Science and Engineering Laboratories
Steve Pollack
Office of Surveillance & Biometrics
Susan Gardner
Office of In Vitro Diagnostic Device Evaluation & Safety
Alberto Guiterrez
Office of OmbudsmanDavid Buckles
Regulations & PolicyNancy Stade
Sr. Associate DirectorLillian Gill
510(k) Program StaffMarjorie Shulman
21 CFR 870.187521 CFR 870.1875
StethoscopeStethoscope
Classification and 510(k)
Pro Code: LDE Pro Code: LDE Manual Stethoscope Manual Stethoscope Class 1 510(k) Exempt Class 1 510(k) Exempt
Pro Code: DQDPro Code: DQD Electronic Stethoscope Electronic Stethoscope Class 2 510(k) Required Class 2 510(k) Required
Pro Code: DQDPro Code: DQD Electronic Stethoscope Electronic Stethoscope Class 2 510(k) Required Class 2 510(k) Required Pro Code: OCR Pro Code: OCR
Lung Sound Monitor Lung Sound Monitor Class 2 510(k) Required Class 2 510(k) Required
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
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
Reports & Public Documents
510(k) Internal Evaluationshthttp://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM220784.pdf
510(k) IOM Reporthttp://www.iom.edu/Activities/PublicHealth/510KProcess.aspx
510(k) Science Reporthttp://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM220783.pdf
CDRH 510(k) Action Planhttp://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm239448.htm
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???
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
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
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?
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.
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
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
FDA Warning Letter Increase
FDA LETTERS ISSUED 2005 - 2010
CDRH Warning Letter Increase
CDRH LETTERS ISSUED 2002 - 2010
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
So what does it all mean?
There is clearly a desire at FDA to demonstrate changeThe fallout from all of these initiatives even prior to formal adoption
of new policies is profoundWhere these changes will ultimately net out?Will that delicate balance be restored?
What will be the ultimate effect on public health?
So what can you do…
Understand the new realityGet involved in the processChoose projects carefullyWatch for curveballsUtilize the global marketAnticipate further changes
Don’t Give Up!
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THANK YOU!