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

Transcription

1 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

2 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 2

3 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 3 3

4 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 4

5 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

6 MDSAP participation 6

7 MDSAP participation (cont.) 7

8 Post-Inspection Follow-up Be responsive to findings Develop a plan with clear timelines and deliverables Conduct systemic review and corrective actions Provide clear, well-organized responses Provide reasonable and timely updates on progress 8

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10 Assessing Benefit-Risk Benefit Risk Other Factors 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 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 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 10

11 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 11

12 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 12

13 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 13

14 CDRH Strategic Priorities 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 14

15 Are we playing Whack-A-Mole? 19

16 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. Over 85% of respondents see Quality's primary Role as enforcing Compliance 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. 20

17 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 htm 21

18 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 22

19 Current engagement paradigm FDA Traditional Regulatory Approaches Enforcement Focused Limited data focused on compliance Resource intensive reviews Industry 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 23

20 Case for Quality Why 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 What 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 How Quality maturity appraisals Outcome performance analytics and dashboards Critical-To-Quality PMA Reviews 24

21 Direct Value Across Stakeholders 78% of respondents listed regulatory need to refile as largest barrier to product modifications FDA 30-Day Notices consumed FTEs Site Changes consumed 5 FTEs Manufacturers 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 Patients 11 product quality improvements at one facility to patients 60-days sooner Faster implementation of corrections to safety issues Healthcare Providers Product performance transparency Safety Effectiveness Reliability Usability Availability Compatibility Patient Experience 25

22 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 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 preapproval inspections FR for the October 10, 2017 Public Meeting 26

23 Where is CfQ Going? 2017 FDA announces a voluntary, quality focused program ready to pilot Focus on 2020 Voluntary program pilot Management of results using quality tools Begin collecting and monitoring outcome metrics 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/post market decisions Leverage real world data for regulatory decisions 27

24 PMA CtQ Pilot What is the pilot? What Does FDA get? What changes? Early interaction with FDA through pre-submission process on device characteristics that are critical to quality and how they are controlled Earlier engagement on manufacturing reviews Improved understanding of essential device features and manufacturing processes Waive preapproval inspection prior to PMA decision Conduct a focused inspection after PMA approval decision FR for the PMA CtQ Pilot 28

25 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 29

26 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 30

27 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 31

28 CDRH Total Product Life Cycle CDRH ODE OC OSB OIR OSEL OCE OM 32

29 ODE OC OSB 33

30 CDRH Total Product Life Cycle CDRH Device Specific Offices OIR OSEL OCE OM 34

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32 TPLC Goals Organic connections within the organization Fuller picture of device, firm, industry Streamlined decisions and processes Shared priorities Professional growth 36

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