OMTEC 2015 CDRH Device Quality Update · OMTEC 2015 CDRH Device Quality Update June 18, 2015 1 ......
Transcript of OMTEC 2015 CDRH Device Quality Update · OMTEC 2015 CDRH Device Quality Update June 18, 2015 1 ......
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OMTEC 2015 CDRH Device Quality Update
June 18, 2015
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William C. MacFarlandandNazia RahmanFDA/CDRH/OC/Division of Manufacturing and Quality
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Agenda• Case for Quality Stakeholder Forum• Library of Quality Practices• Data Transparency• Quality Measures• Critical to Quality (CtQ)
– Implantable Devices/Battery Pilot– DMQ CtQ Info Documents– PMA CtQ Confirmation Pilot
• Questions and Answers2OMTEC 2015
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1: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/MedicalDeviceQualityandCompliance/ucm378185.htm2: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/MedicalDeviceQualityandCompliance/ucm378185.htm
FDA and Device Quality• Current approach reinforces compliance
not necessarily quality1
• Case for Quality2 activities– Projects that encourage operating above the
regulatory baseline– A forum for engaging on the device quality
arena
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FDA and Device Quality• Stakeholder Forum
– MDIC has convened this forum1
– Researching use of Quality Maturity Models– Regular meetings to discuss:
• Areas for improving quality• Chartering new approaches• Updates on projects
– Some meetings targeted, some broad in scope
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1: http://mdic.org/case-for-quality-cfq/
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FDA and Device Quality• (new) FDA Library of Quality Practices
– A resource that promotes building the knowledge-base on device quality.
– Working with other organizations but also making our own internal training material more readily available
– Look for more on this concept as we develop it throughout 2015.
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FDA and Device Quality• Quality Measures
– Interested in indicators of product quality– Identifying measures tied to best practices– Preproduction, production and post-
production– Workgroup comprised of industry and agency
personnel• Expecting compilation of measures by
mid-year and discussion at MDIC.OMTEC 2015 6
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FDA and Device Quality• Data Transparency
– Stakeholder needs assessment– Informed Inspections– Application Programming Interface (API)– 3rd party data analysis
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FDA and Device Quality• Critical to Quality (CtQ)
– Started as an inspection pilot– “CtQs” generated via:
• Internal CDRH and ORA experts• Technical stakeholder input
– CtQs written into inspectional guidance• Shared with investigators• Shared with firms being inspected
– 4 inspections completedOMTEC 2015 8
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2014 CtQ Info DocumentsCtQ Information Document Who was involved?
Implantable/ Battery FDA Pilot CDRH WG, Battery Suppliers, OEMs
Implantable spine device PMA post-approval ODE/ASDBSemi-constrained knee implants, RBWP ODE/JFDB1Abdominal surgical mesh RBWP and PMAs ODE/GSDB1, ULDB, GEDB,
RNDB and OGDBImplantable cardioverter defibrillators ODE/IEDB, AdvaMed WG
Defibrillator leads ODE/IEDB, AdvaMed WGNeuro embolization devices ODE/NNDB, AdvaMed WGInfusion pumps ODE/GHDB, AdvaMed WGVentilators ODE/RDB, AdvaMed WG
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-Nazia Rahman
THE CTQ PROCESS
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The CtQ Process• Four process steps: Steps A-D:
– Step A: identify top 10 key characteristics for the device
• Work with other CDRH offices and field staff to identify:
– Device user and end user– Key failure modes– The top key characteristics of the device – The impact of failure to meet the characteristic and the
impact of the failure on the device/user/patient
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The CtQ Process– Step B: identify how these characteristics are
controlled in design and manufacturing• Essential Design Outputs• Supplier Agreements• Acceptance Testing• Process Flow• Specifications
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The CtQ Process– Step C: draft CtQ Indicators
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Key characteristic
Impactof failure
Control
Reference to 820 Reference to QSIT
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The CtQ Process• Step D: (where possible) Validate with
technical stakeholder input
• Step D is the critical step – it helps close the perception gap on quality
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FDA and Device Quality(New) PMA CtQ Confirmation Pilot• Participants will meet the following criteria
– PMA manufacturing sections have no deficiencies in the original submission
– Applicant has been inspected within the last five years– Applicant is willing to participate
• Applicant submits CtQs. FDA reviews.• Preapproval confirmation of controls.• Postapproval QSIT
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FDA and Device Quality• Look for further opportunities to interact on
device quality with FDA• In the meantime, consider asking:
– What does the term “quality” mean to me? How do we use this term at our company?
– Are our company’s current high-priority projects focused on quality system execution? Are they focused on ensuring overall device quality?
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Contact Information
FDA, Center for Devices and Radiological HealthOffice of ComplianceDivision of Manufacturing and QualityBuilding WHITE OAK #6610903 New Hampshire AvenueSilver Spring, MD 20993
OMTEC 2015
Bill MacFarlandDirector, Division of Manufacturing and
QualityTel: 301-796-5547Email: [email protected]
Nazia RahmanBiomedical EngineerPhysical Medicine, Orthopedics,
Neurology, Dental Devices BranchTel: 301-796-3849Email: [email protected]
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