1

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

1

2

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

3

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

4

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%

5

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

6

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

7

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

8

The Case for Quality – Implementation Plan

• Initiative 1: Focus on quality

• Initiative 2: Enhanced transparency

• Initiative 3: Stakeholder engagement

9

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

10

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?

11

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

12

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

13

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

14

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

15

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

16

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

17

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

18

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

19

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

20

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

21

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

22

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?

24

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

25

Your Role

•Engagement

•Feedback

•Incentives

26

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

28

29

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

30

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.

31

Thank you

32