CDRH’s Inspection Strategy for 2018: How it Will Impact Your Company

CAPT Sean M. Boyd, MPH, USPHS Deputy Director for Regulatory Affairs

CDRH Office of Compliance

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Patients are at the Heart of What We Do

CDRH Vision Patients in the U.S. have access to high-quality, safe, and effective

medical devices, of public health importance, first in the world

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Inspections and Site Selection

A risk-based approach for routine surveillance and targeted inspections

• Novel devices • Rapidly evolving technology • Compliance history • Adverse event trends • Experience from reviews and interactions

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FDARA

Flexibility to inspect medical device facilities based on risk

Greater predictability and transparency to the inspection process

Ability to recognize international auditing organizations for inspection purposes

www.fda.gov

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Medical Device Single Audit Program

• Single regulatory audit of firm’s quality management system satisfies needs of multiple regulatory jurisdictions

• Substitute for FDA routine surveillance inspections – For-cause, follow-up, pre-approval, post-approval

inspections not currently affected • Pilot through December 2016, implementation in

2017

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MDSAP participation

www.fda.gov

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MDSAP participation (cont.)

www.fda.gov

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Post-Inspection Follow-up

Provide reasonable and timely updates on progress

Provide clear, well-organized responses

Conduct systemic review and corrective actions

Develop a plan with clear timelines and deliverables

Be responsive to findings

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Assessing Benefit-Risk

Benefit

• Type of Benefit • Magnitude of benefit(s) • Likelihood patients

experience one or more benefits

• Duration of effects • Patient preference on

benefit • Benefits for healthcare

professionals or caregivers

• Medical necessity

Risk

• Risk Severity • Nonconforming product

risks • Duration of exposure to

population • False positive or false

negative results • Patience tolerance of

risk • Risk factors for

healthcare professionals or caregivers

Other Factors

• Uncertainty • Mitigations • Detectability • Failure mode • Scope of the device issue • Patient impact • Preference for

availability • Nature of violations/ • Nonconforming product • Firm compliance history

Goals: arrive at the same risk determination, weigh options while minimizing disruption of care and protecting public health

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Impact on Decision Making

Assessment indicates high benefits to patients with

little risk

FDA works with manufacturer

interactively or without formal enforcement

action

Assessment indicates low benefits to patients with

high risk

FDA takes compliance or

enforcement action to address problem

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Least Burdensome Approach Expanded Application Incorporates Benefit-Risk Tradeoffs

• FDA should request the minimum information necessary to adequately address the right regulatory question or issue

• Industry should submit material to FDA, including premarket submissions, that are least burdensome for FDA to review

• The most efficient means should be used to resolve regulatory questions and issues

www.fda.gov

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Least Burdensome Approach Expanded Application Incorporates Benefit-Risk Tradeoffs

• Provide the right information at the right time • Regulatory paradigms should be designed to

fit the technology • Leverage data from other countries and

decisions by national medical device regulatory authorities to the extent appropriate and feasible

• Apply least burdensome principles in international medical device convergence and harmonization efforts

www.fda.gov

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CDRH Strategic Priorities

2014-2015 2016-2017 Strengthen the Clinical Trial

Enterprise Establish a National Evaluation

System for Medical Devices (NEST)

Strike the Right Balance Between Premarket and

Postmarket Data Collection

Partner with Patients

Provide Excellent Customer Service

Promote a Culture of Quality and Organizational Excellence

www.fda.gov

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Are we playing Whack-A-Mole?

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Barriers to Quality • The focus of the relationship between FDA and

industry on managing compliance rather than on a shared goal for continuously improving quality.

• A perceived and real lack of transparency and comparative data hampers informed decision making by users, purchasers, and the FDA, and thwarts rewarding good performers.

Over 85% of respondents see Quality's primary Role as enforcing Compliance

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Compliance ≠ Quality

“…one device manufacturer can meet FDA requirements and still make a poor quality device whereas

a second manufacturer may not comply with all FDA requirements

and yet make a high-quality device”

Jeff Shuren, M.D., J.D., Director CDRH

Compliance with the regulations is still important, as it is required – a high quality product is not a substitute for a compliant product under our current statutory situation http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/MedicalDeviceQualityandCompliance/ucm378185.htm

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Miriam-Webster Says

Compliance

• The act or process of complying to a desire, demand, proposal, or regimen or to coercion

• Conformity in fulfilling official requirements

Quality

• Degree of excellence • Superiority in kind

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Current engagement paradigm FD

A • Traditional Regulatory Approaches

• Enforcement Focused

• Limited data focused on compliance

• Resource intensive reviews

Indu

stry

• Defensive • Opaque • Resources

spent on protecting from FDA instead of improvement and innovation

• Generating artifacts to satisfy regulators, sometimes with limited intrinsic value

62% of respondents listed regulatory and government as the number one business

disrupter

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Case for Quality • Risk to patients from poor quality products and hampered innovation in

device manufacturing • Lack of competition around medical device quality • Industry focus on meeting regulatory requirements instead of adopting

best quality practices • Lack of investment in new technologies

Why

• Collaborative effort that focuses on organizational excellence and product quality

• Transparency on product quality to enable market drivers • Modified FDA review and oversight. Enhanced performance data with

reduced regulatory burden

What

• Quality maturity appraisals • Outcome performance analytics and dashboards • Critical-To-Quality PMA Reviews How

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Direct Value Across Stakeholders FD

A • 30-Day Notices consumed 15-22 FTEs

• Site Changes consumed 5 FTEs

Man

ufac

ture

rs

• FDA audit cost (10 Days) - $140K

• $1.2M/year savings 1 facility based on optimized processes and resource allocation (69 30-Day Notices)

• Limited submissions and improvements due to regulatory resources

Patie

nts • 11 product

quality improvements at one facility to patients 60-days sooner

• Faster implementation of corrections to safety issues

Heal

thca

re P

rovi

ders

• Product performance transparency • Safety • Effectiveness • Reliability • Usability • Availability • Compatibility • Patient

Experience

78% of respondents listed regulatory need to refile as largest barrier to

product modifications

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Voluntary Program Pilot

What is the pilot?

• The pilot involves voluntary participation in a third-party maturity appraisal performed by CMMI.

• A baseline set of effectiveness metrics is collected

• There will be pulse checks of those metrics at 90 – 180 day intervals

What Does FDA get?

• FDA receives a progress report from CMMI of how the quality system is performing at the appraisal

• FDA receives a better set of objective metrics as a baseline to monitor progression and benchmark

• More engagement and feedback on quality objectives

What changes?

•Support and guidance from appraisers on improvement

•Collaboration on driving improvements and issue resolution

•Removal from the surveillance work plan

•Reduction in manufacturing submission requirements and faster approval for implementation

•Waive some pre-approval inspections

FR for the October 10, 2017 Public Meeting https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm568069.htm

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Where is CfQ Going?

www.fda.gov

2018 2019 2020 • Voluntary program pilot

• Management of results using quality tools

• Begin collecting and monitoring outcome metrics

• Focus on improvement and enhancement of the program

• Share outcome indicators publicly

• Expand resources for new innovators and firms struggling with compliance

• Expand program options and tools

• Improve premarket/postmarket decisions

• Leverage real world data for regulatory decisions

2017 • FDA

announces a voluntary, quality focused program ready to pilot

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PMA CtQ Pilot

What is the pilot?

• Early interaction with FDA through pre-submission process on device characteristics that are critical to quality and how they are controlled

What Does FDA get?

• Earlier engagement on manufacturing reviews

• Improved understanding of essential device features and manufacturing processes

What changes?

• Waive preapproval inspection prior to PMA decision

• Conduct a focused inspection after PMA approval decision

FR for the PMA CtQ Pilot https://www.federalregister.gov/documents/2017/09/12/2017-19258/center-for-devices-and-radiological-health-premarket-approval-application-critical-to-quality-pilot

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• Started September 29, 2017 – First nine (9) participants meeting participation

criteria, first served • Participation Criteria

– “Right First Time” PMA Manufacturing Section – Clean 5-year inspectional history and compliance record – ***Excludes combination products, products regulated

by CBER, companion diagnostic and IVDs requiring coordination with CDER

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• Pre-PMA Q-submission – Provide a statement of interest, impacted facilities, critical

characteristics (if available) • Q-submission meeting

– Discuss program expectations, feedback on critical characteristics and associated controls

• PMA application review – Review manufacturing section with CtQ information,

streamlined process validation report • Inspection following decision

– Based on critical device characteristics and controls, developed jointly by FDA and PMA applicant

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What’s Right for You?

MDSAP

• Compliance audit meeting multiple international jurisdictions

• Replaces routine FDA surveillance inspection

PMA CtQ

• Engagement with FDA on key device characteristics, manufacturing controls

• Faster PMA decision, targeted inspection following approval

Voluntary Program

• Maturity appraisal identifying value provided to customers and business

• Replaces routine surveillance inspection, streamlines PMA 30 day notice and site change reviews, fosters interactive approach with FDA

FR for the PMA CtQ Pilot https://www.federalregister.gov/documents/2017/09/12/2017-19258/center-for-devices-and-radiological-health-premarket-approval-application-critical-to-quality-pilot

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CDRH Total Product Life Cycle CDRH

ODE OC OSB OIR OSEL OCE OM

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ODE OC OSB …

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CDRH Total Product Life Cycle CDRH

Device Specific Offices

OIR OSEL OCE OM

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TPLC Goals

www.fda.gov

Organic connections within the organization

Fuller picture of device, firm, industry

Streamlined decisions and processes

Shared priorities

Professional growth