AFDO Educational AFDO Educational Conference:Conference:

FDA Quality InitiativesFDA Quality Initiatives

Ricky Rodriguez, DirectorRicky Rodriguez, Director

FDA Dallas District OfficeFDA Dallas District Office

Steve Silverman, DirectorSteve Silverman, Director

CDRH Office of ComplianceCDRH Office of Compliance

June 25, 2014June 25, 2014 1

AgendaAgenda

•Why a quality strategy?Why a quality strategy?•How does quality differ from How does quality differ from compliance?compliance?•FDA Quality Initiatives:FDA Quality Initiatives:

– The Case for Quality (CfQ)The Case for Quality (CfQ)– The Voluntary Compliance The Voluntary Compliance

Improvement Pilot (VCIP)Improvement Pilot (VCIP)•The Office of Compliance ReorganizationThe Office of Compliance Reorganization

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Why a Quality Strategy?Why a Quality Strategy?

• We are consistently

seeing a high volume

of the same issues

year after year

• We must ask whether

we are using the right

methods to improve

device quality

2005-2013 Inspections with OAI Outcomes2005-2013 Inspections with OAI Outcomes

2005-2013 FDA Form 483 Observations 2005-2013 FDA Form 483 Observations

Why a Quality Strategy?Why a Quality Strategy?

95

66

InspectedInspected

Not inspectedNot inspected

Percent of firms inspected

Domestic; Annual

Percent of firms inspected

Foreign; Annual

122 Warning Letters were issued in the 2012 calendar year

– 3.8% of total investigations resulted in a Warning Letter

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Quality Versus Compliance: Current StateQuality Versus Compliance: Current State

Business Business

ObjectivesObjectivesQuality ObjectivesQuality Objectives

ComplianceCompliance

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Quality Versus Compliance: Future StateQuality Versus Compliance: Future State

Business

Objectives

Quality Objectives

Compliance

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CDRH

FDA Quality InitiativesFDA Quality Initiatives

ORA

Stakeholders

CfQ & CfQ &

VCIPVCIP

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The Case for Quality The Case for Quality • Support and ownership of quality go beyond Support and ownership of quality go beyond

quality/compliance unitsquality/compliance units

• A culture of quality yields benefits.A culture of quality yields benefits.

• Recent trends highlight the importance of quality.Recent trends highlight the importance of quality.

• ““Understanding Barriers to Medical Device Quality”Understanding Barriers to Medical Device Quality” http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobaccohttp://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/UCM277323.pdf/CDRH/CDRHReports/UCM277323.pdf

• October 31, 2011 webcast:October 31, 2011 webcast: http://fda.yorkcast.com/webcast/Viewer/?peid=7134123bd5c94d909fdae41fce3469411d

• http://fda.yorkcast.com/webcast/Viewer/?peid=7134123bd5c94d909fdae41fce3469411d

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The Case for Quality The Case for Quality Implementation PlanImplementation Plan

Initiative 1: Focus on QualityInitiative 1: Focus on Quality

Initiative 2: Enhanced TransparencyInitiative 2: Enhanced Transparency

Initiative 3: Stakeholder EngagementInitiative 3: Stakeholder Engagement

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What have we heard?What have we heard?

StakeholdersStakeholders

1.1. Safe communicationsSafe communications

2.2. CollaborationCollaboration

3.3. Inspection engagementInspection engagement

4.4. Critical to qualityCritical to quality

5.5. Clear expectationsClear expectations

6.6. IncentivesIncentives

InternallyInternally

1.1. CommunicationsCommunications

2.2. CollaborationCollaboration

3.3. Inspection engagementInspection engagement

4.4. Critical to qualityCritical to quality

5.5. Clear expectationsClear expectations

6.6. IncentivesIncentives

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2014 Case for Quality Activities2014 Case for Quality Activities

1. Engage industry and other stakeholders in national venues

2. Engage industry and FDA districts in local venues

3. Partner with industry and other stakeholders to develop

collaborative forums and trustful engagements

Stakeholder Stakeholder

EngagementEngagement

Data TransparencyData Transparency1. Provide relevant device quality data

2. Gather and assess stakeholder data needs

3. Develop a framework for delivering releasable information

Activities Sub-Initiative

Focus on QualityFocus on Quality 1. Develop, implement, and assess a pilot that changes engagement

during an inspection

2. Assess internal/external incentives and measures

3. Benchmark with other quality performance models

Case for Quality: Battery PilotCase for Quality: Battery Pilot

•Implantable Battery-Containing DevicesImplantable Battery-Containing Devices

•Up to 5 ManufacturersUp to 5 Manufacturers

•Inspections focused on factors that affect Inspections focused on factors that affect device qualitydevice quality

•Prioritized Form FDA-483sPrioritized Form FDA-483s

•Does the pilot improve quality and Does the pilot improve quality and resource allocation?resource allocation?

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Spin Off

Update Program

Successful pilots can be expanded.Successful pilots can be expanded.

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The Voluntary Compliance The Voluntary Compliance Improvement PilotImprovement Pilot

• CDRH Strategy 4.2. Establish a Voluntary CDRH Strategy 4.2. Establish a Voluntary Compliance Improvement Pilot ProgramCompliance Improvement Pilot Program– Goal 4.2.1. By September 30, 2013, CDRH will take Goal 4.2.1. By September 30, 2013, CDRH will take

steps to move certain manufacturers at risk of steps to move certain manufacturers at risk of compliance action . . . to a state of improved compliance action . . . to a state of improved performance by allowing these manufacturers to performance by allowing these manufacturers to enter into a remediation agreement with the enter into a remediation agreement with the agency . . . .agency . . . .

– By September 30, 2013, launch the Voluntary By September 30, 2013, launch the Voluntary Compliance Improvement Pilot Program.Compliance Improvement Pilot Program.

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• Up to 5 manufacturersUp to 5 manufacturers• Alternative to surveillance inspectionsAlternative to surveillance inspections• Expert consultants certify that participants Expert consultants certify that participants

have defined problems, analyzed root causes, have defined problems, analyzed root causes, and taken effective corrective action.and taken effective corrective action.

• Manufacturers self-identify and correct Manufacturers self-identify and correct deficiencies; FDA redirects resources to firms deficiencies; FDA redirects resources to firms unable to take these steps.unable to take these steps.

Voluntary Compliance Voluntary Compliance Improvement PilotImprovement Pilot

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