OMTEC 2015 CDRH Device Quality Update

June 18, 2015

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William C. MacFarlandandNazia RahmanFDA/CDRH/OC/Division of Manufacturing and Quality

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

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/

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

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

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

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

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Bill MacFarlandDirector, Division of Manufacturing and

QualityTel: 301-796-5547Email: william.macfarland@fda.hhs.gov

Nazia RahmanBiomedical EngineerPhysical Medicine, Orthopedics,

Neurology, Dental Devices BranchTel: 301-796-3849Email: nazia.rahman@fda.hhs.gov