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

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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!