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Steven Silverman, Director CDRH Office of Compliance
Update on FDA’s case for Quality and Key CDRH Compliance Initiatives AFDO Annual Educational Conference June 11, 2013
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Today’s Agenda: • FDA’s Case for Quality
–What has FDA heard? –What had FDA done & what will it do?
• The Medical Device Single Audit
Program
• The Voluntary Compliance Improvement Pilot
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The number of inspections with OAI outcomes has remained high, with frequent recurrences
• 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
Inspections with OAI outcomes over time
177240200145150175190195205
2012
11
10
09 08 07
06 05 2004
Percent Warning Letters with CAPA or DC citation Percent of Warning Letters
020406080
100
2004 2005 2006 2007 2008 2009 2010 2011
CAPA Design Control
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FDA only inspects a portion of firms, requiring us to consider other strategies
95
66
Inspected
Not 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 investigations1 resulted in a Warning Letter
1 Counts both domestic and foreign investigations
26%
74%
3%
97%
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The Case for Quality • Support and ownership of quality go beyond
the quality/compliance units
• A culture of quality yields benefits: • Enhanced process stability drives productivity and performance • Cross-functional skills and collaboration correlate to enhanced
performance and productivity • Prevention reduces compliance risks and costs • Best plants have fewer complaints and investigations
• Recent trends highlight the importance of quality:
• Rapid growth of the U.S. device industry • Adverse event reports outpace market growth • Risks are unevenly distributed across product types • Design failures consistently account for about ½ of all recalls
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Barriers to Quality
• Increasing complexity of devices and use environments with static quality practices
• The relationship between quality and compliance – historically more focus on compliance than quality
• Historically underutilized comparative quality information
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Recent research suggests that quality has a strong impact on firms’ market position
• Quality issues can impair or enhance market reputation
• Quality failures or failure prevention efforts affect costs
• The impact of quality on customer satisfaction can alter revenues
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The Case for Quality – Implementation Plan
• Initiative 1: Focus on quality
• Initiative 2: Enhanced transparency
• Initiative 3: Stakeholder engagement
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Focus on Quality
• Focus on quality • Enhance focus on quality
while maintaining compliance
• Promote a root-cause approach to quality challenges
• Enhanced transparency
• Stakeholder engagement
Focus on quality
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Good quality practices, not just compliance
Focus on quality
• More focus on practices that lead to quality outcomes that go beyond compliance
• Regulatory emphasis on preventive quality practices • Companies view compliance as part of achieving
overall quality, not the ultimate goal • Focus on identifying and addressing underlying
causes of quality issues
What is the Focus on Quality?
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FDA placing greater emphasis on quality
Focus on quality
Current state Future state • FDA assesses firms' quality
practices against the Quality System Regulation (QSReg)
• FDA’s interaction with firms is mainly focused on compliance
• Some firms focus on FDA observations rather than focus on underlying causes
• FDA will continue to assess firms’ compliance with the QSReg
• FDA and industry emphasize that good quality practices drive better products and protect public health
• FDA focuses interactions with firms utilizing root cause analysis, designing quality into the product, and optimizing corrective actions
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Focus on quality team’s activities
Focus on quality
• Promote a focus at FDA on root-cause analysis • Unify approach at FDA: develop internal FDA root-cause training and
develop common language and approach Promoting root-cause approach
More focus on effectiveness and building in quality
• Update compliance approach to focus on the effectiveness of corrective actions
• Shift FDA compliance focus away from QA resources to quality in product development
Description Preliminary ideas
Communicate FDA’s Focus on Quality
• Communicate FDA focus on good quality practices, not just compliance
• Ongoing conversation with industry and other stakeholders to help drive implementation
• FDA outreach to change perception that investigators use a checklist approach to inspections
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Comparative quality transparency • Focus on quality
• Enhanced transparency • Data transparency:
– Drive quality by improving ease of access to information – Provide one integrated data source that affords maximum
flexibility
• Improved analyses: – Leverage Agency data to refine FDA’s initiatives – Provide consistent and regular publically available analyses
• Stakeholder engagement
Enhanced transparency
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Problem Statement
•How can FDA act to help ensure that stakeholders (industry, agencies,
device purchasers, patients, and payers) incorporate differentiating quality
data into their decisions?
Enhanced transparency
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Provide information to support data-driven decisions
Enhanced transparency
• Data transparency: Through query interfaces, FDA shares pre-market, adverse event, registration and listing, recall, and inspection information
• Ad hoc analyses provided: FDA provides infrequent and varying analyses and FY compliance activities
• Enhanced data transparency: FDA provides a flexible, comprehensive, updated database structured for analysis
• Improved analyses provided: FDA provides consistent, predictable analyses of compliance data to support device quality improvements
Current state Future state
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Future public reporting engine and support
• More than just flat html display • Support on-site analysis • Provide canned reports for public use
• CDRH control over reports • Creation of new reports by CDRH • Engagement with stakeholders on value-added
data and reports • Supplementary explanation of available
data fields • Help to minimize data pitfalls • Encourage accurate data analysis by assisting
the public in understanding data
Enhanced transparency
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Program baselines and trending analysis will be one analytic focus
Example areas for exploration: • Quarterly automated device
analysis • Cover “device groups” • Total Product Life Cycle
data • Premarket data • Recall root causes • MDRs
• Center activity snapshot by device group
• Where the action is • Where there might be an
over-arching issue • The state of overall device
quality
Enhanced transparency – improved analyses
Premarket Submissions
Reg Firms
1,200
600
400
200
0
Combination
Pediatrics
Implants
Premarket Submissions
Registered Firms
Shipped Devices
India
Mexico
China
Example analyses: Registered firms and premarket submissions by industry
Import information by market of origin
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Stakeholder Engagement
•Focus on quality
•Enhanced Transparency
•Stakeholder engagement – Forums that explore the issues, supporting
a transition to a quality-focused model – Strategies to actively collaborate beyond
these forums
Stakeholder engagement
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FDA’s stakeholder engagement initiative enhances communication among stakeholders: • Multiple engagement touch-points between FDA,
industry, and other stakeholders to: –More effectively communicate expectations –Solicit input from on changes and improvements
• A change-management program to promote optimal
quality practice
• A project management structure to support this initiative and monitor its impact
Stakeholder engagement
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FDA is engaging via a set of forums
• Cadence of FDA interactions with leaders of medical device companies and other stakeholders
• Objective is to: – More effectively communicate expectations – Solicit input on changes and improvements
Central forums
• Cadence of ORA district-connected interactions with medical device companies and other stakeholders
• Objective is to: – More effectively communicate expectations – Solicit input on changes and improvements
Field forums
Current practice platform
• Platform to share FDA and device company experience on recent quality practices
• Data collaboration will inform these discussions
Description Preliminary ideas
Stakeholder engagement
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FDA will track progress of the initiatives
• Evaluate progress towards finalizing ongoing initiatives
Program metrics
• Evaluate impact of each finalized initiative
Impact metrics
Description
• Qualitative statements showing whether sufficient progress has been made
Qualitative input on progress
Stakeholder engagement
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What did we hear in 2012? • Stakeholders
• Safe communications • Collaboration • Inspection Engagement
• Not focused on critical to quality • No clarity of expectations
• Incentives
• Internally • Communications • Collaboration • Inspection engagement
• Not focused on critical to quality • No clarity of expectations
• Measures/Incentives
DRAFT-CONFIDENTIAL 23
What did we learn in 2012? • Industry and FDA share frustrations
• The current regulatory framework can adapt
• It will take work to manage the change:
• Build trust on both sides • Pilot new ways to interact • Identify knowledge gaps • Demonstrate benefits to both sides
• What are the steps to begin making these
changes?
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2013 Case for quality activities
• Engage industry and other stakeholders in national venues • Engage industry and FDA districts in local venues • Partner with industry and other stakeholders to develop
collaborative forums and trustful engagements
Stakeholder engagement
Comparative data transparency
• Provide relevant device quality data • Gather and assess stakeholder data needs • Develop a framework for delivering releasable information
Activities Sub-Initiative
Focus on quality
• Develop, implement, and assess a pilot that changes engagement during an inspection
• Identify and pilot means of collaboration and communication on observations
• Assess internal/external incentives and measures • Benchmark with other quality performance models
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Your Role
•Engagement
•Feedback
•Incentives
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Australia Therapeutics Goods Administration
Brazil Agência Nacional de Vigilância Sanitária
Canada
Health Canada/Santé Canada
United States of America Food and Drug Administration http://www.fda.gov/InternationalPrograms/Agreements/MemorandaofUnderstanding/ucm330179.htm
MDSAP Goals • A single audit to satisfy the regulatory
requirements of multiple participants
• More effective, efficient, and less burdensome regulatory oversight of the quality management systems of medical device manufacturers
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MDSAP Key Strategies: • A single audit program • Appropriate regulatory oversight/reduced regulatory
burdens • More efficient and flexible use of regulatory resources
• Greater global alignment of regulatory approaches and
technical requirements • Promote consistency, predictability, and transparency of
regulatory programs
• Leverage existing conformity assessment structures
Pilot • January 1, 2014 - recognition of initial
participating Auditing Organizations • June 1, 2014 – some Auditing
Organizations to begin auditing medical device manufacturers; more will be added as the pilot progresses
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The Voluntary Compliance Improvement Pilot
• CDRH Strategy 4.2. Establish a Voluntary Compliance Improvement Pilot Program – Goal 4.2.1. By September 30, 2013, CDRH will take
steps to move certain manufacturers at risk of compliance action . . . to a state of improved performance by allowing these manufacturers to enter into a remediation agreement with the agency . . . .
– By September 30, 2013, launch the Voluntary Compliance Improvement Pilot Program.
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Thank you
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