1 cdrh update facilitating medical device innovation and technology dan schultz, md director, center...

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CDRH UpdateCDRH UpdateFacilitating Medical Device Innovation and Facilitating Medical Device Innovation and

Technology Technology

Dan Schultz, MDDan Schultz, MDDirector, Center for Devices and Radiological HealthDirector, Center for Devices and Radiological Health

Food and Drug AdministrationFood and Drug Administration

Sixth Annual National Forum on Biomedical Imaging in OncologySixth Annual National Forum on Biomedical Imaging in OncologyBethesda, MDBethesda, MDApril 7, 2005April 7, 2005

22

What is a What is a Device?Device?

33

A Computer That Helps You HearA Computer That Helps You Hear

44

Miniaturized DevicesMiniaturized DevicesElectrical StimulatorsElectrical Stimulators

PacemakersPacemakers

55

Information-Rich TherapeuticsInformation-Rich TherapeuticsInformation-Rich TherapeuticsInformation-Rich Therapeutics

InsulinDeliveryCatheter

Intravascular Glucose sensor

Implantable Sc pump

PersonalProgrammingCommunicator

“ “Smart” Drug Delivery DevicesSmart” Drug Delivery Devices

66

Combination ProductsCombination ProductsDrug-Eluting StentsDrug-Eluting Stents

ComponentsComponents

Stent Platform & Stent Platform & Delivery SystemDelivery System

Carrier(s)Carrier(s)

DrugDrug

77

Intelligent DevicesIntelligent DevicesStent as a Radiofrequency IdentifierStent as a Radiofrequency Identifier

Preclinical Model of Self Monitoring StentPreclinical Model of Self Monitoring Stent

Applications: detect restenosisApplications: detect restenosis

Measure blood pressure continuouslyMeasure blood pressure continuously

Yogesh Gianchandani and his team at the University of Michigan Yogesh Gianchandani and his team at the University of Michigan

88

Information Rich TherapeuticsInformation Rich TherapeuticsDiagnostics and Therapeutic DeviceDiagnostics and Therapeutic Device

Uses magnetic resonance image (MRI) guided focused ultrasound Uses magnetic resonance image (MRI) guided focused ultrasound to to targettarget and and destroydestroy non-cancerous uterine fibroids non-cancerous uterine fibroids

Information Rich TherapeuticsInformation Rich TherapeuticsDiagnostics and Therapeutic DeviceDiagnostics and Therapeutic Device

Uses magnetic resonance image (MRI) guided focused ultrasound Uses magnetic resonance image (MRI) guided focused ultrasound to to targettarget and and destroydestroy non-cancerous uterine fibroids non-cancerous uterine fibroids

Minimally Invasive DevicesMinimally Invasive DevicesImage (MRI) Guided Treatment (HiFU)Image (MRI) Guided Treatment (HiFU)

99

Medical Imaging DevicesMedical Imaging Devices

Digital MammographyDigital MammographyProduces images using Produces images using X-rays instead of film X-rays instead of film

Image Analysis Image Analysis SoftwareSoftware Aids in the Aids in the detection of lung detection of lung nodulesnodules

1010

Technology for Special Populations Technology for Special Populations

Left Ventricular Left Ventricular Assist Device for Assist Device for

Pediatric UsePediatric Use

Stair-Climbing WheelchairStair-Climbing Wheelchair

1111

Technology Designed for Home UseTechnology Designed for Home Use

Home Testing for HIVHome Testing for HIV

A Defibrillator for the HomeA Defibrillator for the Home

1212

Point of Care Diagnosis and Therapy Point of Care Diagnosis and Therapy DevicesDevices

Enhancement of point of care testingEnhancement of point of care testing Enhanced portability of increasingly complex Enhanced portability of increasingly complex laboratory analysislaboratory analysis

Example: A portable test has been approved by Example: A portable test has been approved by CBER for HIVCBER for HIV

CDRH expects other high risk technologies to CDRH expects other high risk technologies to followfollow

1313

Biological Medical DevicesBiological Medical DevicesGenomicsGenomics

Impact on Therapeutic ProductsImpact on Therapeutic ProductsNew knowledge about diseaseNew knowledge about diseaseAnimal modelsAnimal modelsPharmacogenomics:Pharmacogenomics:

Identify respondersIdentify respondersUnderstand toxicityUnderstand toxicity

Clinical diagnosisClinical diagnosisClinical treatment monitoringClinical treatment monitoring

Personalized MedicinePersonalized MedicinePersonalized MedicinePersonalized Medicine

1414

Biological Medical DevicesBiological Medical DevicesBiotechnology RevolutionBiotechnology Revolution

Microarray TechnologyMicroarray Technology

Providing insight into Providing insight into patient factors allowing patient factors allowing for personalized for personalized medicinemedicine

AmplichipAmplichip

Personalized MedicinePersonalized MedicinePersonalized MedicinePersonalized Medicine

1515

Technology We Hope We Never Need Technology We Hope We Never Need Bioterrorism Diagnostic TestingBioterrorism Diagnostic Testing

Bioterrorism Diagnostic TestingBioterrorism Diagnostic Testing

Testing for biological warfare agents including Testing for biological warfare agents including microbes and toxic chemicalsmicrobes and toxic chemicals

Biosensor detectors Biosensor detectors

Nucleic acid amplification Nucleic acid amplification

Challenge: Challenge: Studies using real clinical samples may not be possible so flexible regulatory and scientific alternatives

are essential

Challenge: Challenge: Studies using real clinical samples may not be possible so flexible regulatory and scientific alternatives

are essential

QuickELISA Anthrax-Pa Kit The first rapid serum antibody test for anthrax

QuickELISA Anthrax-Pa Kit The first rapid serum antibody test for anthrax

1616

What are the challenges todayWhat are the challenges today

for bringing new medical for bringing new medical

technology to market?technology to market?

Accelerated Pace of Technology and InnovationAccelerated Pace of Technology and Innovation

Complexity of New TechnologyComplexity of New Technology

Technology and InnovationTechnology and Innovation

1717

Traditional Lateral Skull FilmTraditional Lateral Skull Film

The Accelerating Pace of Technology and InnovationThe Accelerating Pace of Technology and Innovation Advances in Medical ImagingAdvances in Medical Imaging

1818


41 CT slices41 CT slices

1919


3-D CT Imaging3-D CT Imaging

2020


2121

Medical Device Industry GrowthMedical Device Industry Growth

0

2000

4000

6000

8000

10000

12000

14000

16000

1998 1999 2000 2001 2002 2003 2004

Ophthalmic

Eletromedical

X-Ray

Dental

Surgical

Instruments

Diagnostics

Dun & Bradstreet Medical Device Firm Data

Number of Manufacturers by YearNumber of Manufacturers by Year

2222

Sales Volume GrowthSales Volume Growth

0

50

100

150

200

250

300

350

1998 2000 2003 2004Year

Bil

lio

ns

of

Do

llar

s Ophthalmic

Electromechanical

X-Ray

Dental

Surgical

Instruments

Diagnostics

Note: No economic adjustment to dollar value

(Billions of Dollars)(Billions of Dollars)

2323

The Complexity of New TechnologiesThe Complexity of New Technologies

Devices are getting smaller Devices are getting smaller – Miniaturization, New Materials, NanotechnologyMiniaturization, New Materials, Nanotechnology

Devices are getting smarter and are providing Devices are getting smarter and are providing more informationmore information– Intelligent DevicesIntelligent Devices– Biotechnology RevolutionBiotechnology Revolution– Personalized Medicine Personalized Medicine – Combination ProductsCombination Products– Information-Rich TherapeuticsInformation-Rich Therapeutics

2424

The Complexity of New TechnologiesThe Complexity of New Technologies

Devices are becoming more convenient for the Devices are becoming more convenient for the patientpatient

– Home Use Home Use

– Minimally InvasiveMinimally Invasive

– Point of Care Diagnostics Point of Care Diagnostics

Devices are responding to heighten homeland Devices are responding to heighten homeland securitysecurity

– Bioterrorism-Related DevicesBioterrorism-Related Devices

Devices are meeting the needs for special Devices are meeting the needs for special populationspopulations

2525

Technology and InnovationTechnology and InnovationFDA RoleFDA Role

Establish Establish reasonablereasonable

assurance of the safety and assurance of the safety and

effectiveness of medical devices effectiveness of medical devices

marketed in the U.S.marketed in the U.S.

2626

Technology and InnovationTechnology and InnovationCDRH ChallengesCDRH Challenges

Effectively Managing a Changing WorkloadEffectively Managing a Changing Workload– Increasing number of expedited submissions, Increasing number of expedited submissions,

combinations products and submissions with combinations products and submissions with clinical dataclinical data

– New Kinds of Scientific ExpertiseNew Kinds of Scientific Expertise

Meeting MDUFMA CommitmentsMeeting MDUFMA Commitments– Performance goalsPerformance goals

– Third-party inspectionsThird-party inspections

Establishing a Premarket/Postmarket BalanceEstablishing a Premarket/Postmarket Balance– Greater degree of scrutinyGreater degree of scrutiny

2727

Medical Device ProgramMedical Device Program

TYPE OF SUBMISSION FY 99 FY 00 FY 01 FY 02 FY 03 FY 04

Original PMA* 64 67 71 49 54 51

PMA Supplement* 557 546 641 645 666 635

Original IDE 304 311 284 312 242 226

IDE Amendment 275 240 206 252 216 167

IDE Supplement 4,127 4,388 4,811 4,724 4,415 4,312

510(k) – 10% with clinical data* 4,458 4,202 4,248 4,320 4,247 3,635

Original HDE 12 11 5 5 10 9

HDE Supplements 4 10 16 16 29 29

Total 9,801 9,775 10,282 10,323 9,879 9,064

* The majority of PMAs and 510(k) applications are subject to fees. Exceptions include small business and pediatric applications.

CDRH: Types and Numbers of Submissions ReceivedCDRH: Types and Numbers of Submissions Received

2828

These are the issues that we face These are the issues that we face everyday…everyday…

Implementation of the Implementation of the Medical Device User Fee Medical Device User Fee and Modernization Act of 2002and Modernization Act of 2002……

… … a complex and comprehensive a complex and comprehensive set of review goals, set of review goals,

becoming more aggressive becoming more aggressive each yeareach year..

… … a complex and comprehensive a complex and comprehensive set of review goals, set of review goals,

becoming more aggressive becoming more aggressive each yeareach year..

2929

The number of The number of expeditedexpedited submissions is growing….submissions is growing….

The number of The number of combination combination

productsproducts is growing… is growing…

… … shortening timeframes shortening timeframes and bringing increasingly and bringing increasingly

complex scientific complex scientific questions…questions…

… … shortening timeframes shortening timeframes and bringing increasingly and bringing increasingly

complex scientific complex scientific questions…questions…

… necessitating new kinds of technical expertise and

new regulatory paradigms

… necessitating new kinds of technical expertise and

new regulatory paradigms

3030

The complexity and need for The complexity and need for clinical dataclinical data is is growing…growing…

Embolic protection Embolic protection devicesdevices

Vascular anastomosis

devices for CABG

Image-guided Image-guided bronchoscopesbronchoscopes

Barbed suturesBarbed suturesGlaucoma shuntsGlaucoma shunts

Daily wear contact lenses

CPAP devices for apnea

… … requiring more in-depth requiring more in-depth review, including occasional review, including occasional

Panel inputPanel input

… … requiring more in-depth requiring more in-depth review, including occasional review, including occasional

Panel inputPanel input

3131

BioterrorismBioterrorismEmergency MeasuresEmergency Measures

Emergency PreparednessEmergency Preparedness - Medical device - Medical device emergency shortages databaseemergency shortages database

Bioterrorism Diagnostics and TestingBioterrorism Diagnostics and Testing - - QuickELISA Anthrax-Pa Kit, the first rapid QuickELISA Anthrax-Pa Kit, the first rapid serum antibody test for anthraxserum antibody test for anthrax

ASTM F2401-04ASTM F2401-04 - “Standard Practice for - “Standard Practice for Security Checkpoint Metal Detector Security Checkpoint Metal Detector Screening of Persons with Medical Devices”Screening of Persons with Medical Devices”

3232

Meeting Technology Meeting Technology Innovation Innovation ChallengesChallenges

3333

Meeting the Challenges Meeting the Challenges of Technology and Innovationof Technology and Innovation

Strategic planning helps us achieve our goals Strategic planning helps us achieve our goals and establish a vision for the futureand establish a vision for the future

Meeting MDUFMA GoalsMeeting MDUFMA Goals

Strengthening our workforce for the 21st Strengthening our workforce for the 21st centurycentury

Enhancing our knowledge managementEnhancing our knowledge management

Achieving a better pre/postmarket regulatory Achieving a better pre/postmarket regulatory balancebalance

3434

CDRH FY 05CDRH FY 05Mission: CDRH promotes and protects the health of the public by

ensuring the safety and effectiveness of medical devices and the safety of radiological products.

Vision: Ensuring the health of the public through out the Total Product Life Cycle (TPLC)

Public Health ImpactMeasure, assess, improve

and communicate our impact on public health

Magnet for ExcellenceAttract and retain a

diverse work force to accomplish our public

health mission

CDRHStrategi

c Goals

Knowledge ManagementEnhance use of information and communication

systems to support TPLC

TPLCAlign CDRH programs to

effectively manage the product life

cycle

Meet MDUFMA performance goals

Strengthen our workforce for the 21st

century

CDRH Prioritie

s

Enhance our knowledge

management

Achieve better pre/postmarket

regulatory balance

Public Health PromotionAssess and improve time to market for medical devicesPublic Health Protection Assess and improve risk management, identifying

and resolving public health hazards

Workforce ExcellenceAttract, develop and retain a highly skilled

and diverse workforce to advance our public

health mission

Scorecard

Key ResultAreas

Knowledge Management Communicating

with our stakeholders to

meet public health challenges

throughout the TPLC

TPLCEffective

Management in Accordance with TPLC Principles

FY 05 MDUFMA performance goalsQuality system for application reviewReview consultsCoA studiesRisk -based inspectionsMedSun and LabSunMedical device reports (MDR)Emergency Measures

Priority hiring Professional developmentExternal expertise (MDFP and other initiatives) Priority

Initiatives

Guidance/standardsTargeted IT initiativesInfrastructure upgradesTurbo 510(k)eConsultCommunicating medical technology

OIVD ModelResearch prioritizationRadiological Health StrategyGHTFOrganizational scorecardsProject management plans Move to White Oak

Technology Development and Innovation

Patient and Consumer Protection

Protecting the Homeland -- Counter Terrorism

Risk-Based Management Practices

Improving FDA's Business Practices

Relationship to

FDA Goals

Patient and Consumer Protection

Empowering Consumers in Public Health

Improving FDA's Business Practices

3535

Priority HiringPriority Hiring

0

5

10

15

20

25

30

35

40

45

50

MedicalOfficers

Engineers Scientists ProjectManagers

ProgramSupport

CSOs Statistician Attorney

FY 04

FY 03

OfficeOfficeHiredHired

FY 03 FY 03

Hired Hired

FY 04FY 04

Two Year Totals Two Year Totals Total MDUFMA Total MDUFMA Hires Hires

(#Shared)(#Shared)

TotalTotal 7575 5757 132 (18 Shared)132 (18 Shared)

OCOC 1010 77 17 (1 Shared)17 (1 Shared)

ODEODE 2929 1515 44 (6 Shared)44 (6 Shared)

OCROCR 44 22 6 (0 Shared)6 (0 Shared)

OIVDOIVD 1111 66 17 (0 Shared)17 (0 Shared)

OSBOSB 66 1111 18 (1 Shared)18 (1 Shared)

OSM/OCDOSM/OCD 44 33 6 (0 Shared)6 (0 Shared)

OSELOSEL 1111 1313 24 (11 Shared)24 (11 Shared)

FY 03 and FY 04 Hires (by Specialty)FY 03 and FY 04 Hires (by Specialty)FY 03 and FY 04 Hires (by Specialty)FY 03 and FY 04 Hires (by Specialty)

3636

Develop training programsDevelop training programsProvide professional and career Provide professional and career development opportunitiesdevelopment opportunities

Science Leadership Education Program Science Leadership Education Program (SLEP)(SLEP)Basic Science Education Program Basic Science Education Program (BSEP)(BSEP)

Develop competency modelsDevelop competency modelsScienceScienceManagementManagementBusinessBusiness

Professional DevelopmentProfessional Development

3737

Since its inception, MDFP has sponsoredSince its inception, MDFP has sponsored over 100 fellows in the programover 100 fellows in the program

www.fda.gov/cdrh/mdfp www.fda.gov/cdrh/mdfp

Since its inception, MDFP has sponsoredSince its inception, MDFP has sponsored over 100 fellows in the programover 100 fellows in the program

www.fda.gov/cdrh/mdfp www.fda.gov/cdrh/mdfp

Premarket reviews and consultsPremarket reviews and consults Human factors issuesHuman factors issues Analysis of device failure modesAnalysis of device failure modes Standards and guidance developmentStandards and guidance development Statistical analysesStatistical analyses

External ExpertiseExternal Expertise

Medical Device Fellowship Program (MDFP)Medical Device Fellowship Program (MDFP)Medical Device Fellowship Program (MDFP)Medical Device Fellowship Program (MDFP)

3838

Guidance DevelopmentGuidance Development

Create a list of high priority guidancesCreate a list of high priority guidances

Establish performance goals Establish performance goals

Develop tracking mechanisms Develop tracking mechanisms

Engage industry stakeholders in the Engage industry stakeholders in the early stages of guidance developmentearly stages of guidance development

3939

Standards DevelopmentStandards DevelopmentRecognition – to have significant influence Recognition – to have significant influence throughout the worldthroughout the world

Participation – to work with national and Participation – to work with national and international committeesinternational committees

CDRH Standards ParticipationCDRH Standards Participation38 development organizations38 development organizations

238 Liaison Reps238 Liaison Reps: : 220 National Committees and 128 220 National Committees and 128 International CommitteesInternational Committees

538 Standards Activities538 Standards Activities: : 365 National and 173 Other 365 National and 173 Other ActivitiesActivities

Utilization Utilization Standards utilization in recent device applications - 55% Standards utilization in recent device applications - 55%

4040

Global Harmonization Task ForceGlobal Harmonization Task Force

Develop guidance documents on basic Develop guidance documents on basic regulatory practicesregulatory practices

Continue participating in GHTF study groupsContinue participating in GHTF study groupsStudy Group 1: regulatory and premarket requirements Study Group 1: regulatory and premarket requirements

Study Group 2: postmarket vigilanceStudy Group 2: postmarket vigilance

Study Group 3: quality systemsStudy Group 3: quality systems

Study Group 4: regulatory auditing of quality systems Study Group 4: regulatory auditing of quality systems

NEW Study Group 5: Clinical EvidenceNEW Study Group 5: Clinical Evidence

Mission: Encourage the convergence of medical device regulatory Mission: Encourage the convergence of medical device regulatory practices worldwide where possible, while ensuring the safety, practices worldwide where possible, while ensuring the safety,

effectiveness, and quality of medical devices.effectiveness, and quality of medical devices.

Mission: Encourage the convergence of medical device regulatory Mission: Encourage the convergence of medical device regulatory practices worldwide where possible, while ensuring the safety, practices worldwide where possible, while ensuring the safety,

effectiveness, and quality of medical devices.effectiveness, and quality of medical devices.

4141

Quality Systems for Application ReviewQuality Systems for Application Review

Focus on selected cross-cutting Focus on selected cross-cutting areasareas

e.g., biocompatibilitye.g., biocompatibilityUse retrospective (post-decision) Use retrospective (post-decision) peer assessments peer assessments Assemble quality assessment teamsAssemble quality assessment teamsContinue with pilot programContinue with pilot program

4242

IT Initiatives IT Initiatives

Premarket Review Premarket Review ModernizationModernization

Postmarket Postmarket Medical Device Medical Device Reporting Reporting (eMDR)(eMDR)

ODE and OC ODE and OC Tracking SystemsTracking Systems

Electronic Electronic Registration and Registration and ListingListing

eConsult eConsult

Image2000Image2000

Turbo 510(k)Turbo 510(k)

4343

IT Initiatives IT Initiatives Image2000 Image2000

Scan outgoing 513g and reduce Scan outgoing 513g and reduce backlogbacklog

Decrease original PMA scanning Decrease original PMA scanning times times

Scanning 510(k) in real timeScanning 510(k) in real time

Electronic copies to eliminate Electronic copies to eliminate need for scanningneed for scanning

4444

IT Initiatives IT Initiatives Turbo 510(k)Turbo 510(k)

Continue pilot Continue pilot eSubmissioneSubmission with industry with industry volunteersvolunteers

Develop Develop eLoadereLoader tool for reviewers, allowing tool for reviewers, allowing copy and paste from copy and paste from eSubmissioneSubmission into into external applicationsexternal applications

Develop eReview tool, a standard 510(k) Develop eReview tool, a standard 510(k) review templatereview template

4545

Research PrioritizationResearch Prioritization

Criteria For Rating Criteria For Rating ProjectsProjects

Regulatory need: PMA and IDE activity

Scientific gaps and technical competence: leading edge products

Public health impact: mortality, morbidity, quality of life

Criteria For Rating Criteria For Rating ProjectsProjects

Regulatory need: PMA and IDE activity

Scientific gaps and technical competence: leading edge products

Public health impact: mortality, morbidity, quality of life

FY 05 GoalsFY 05 Goals

Continue using Continue using prioritization modelprioritization model

FY 04 Update FY 04 Update

73 projects (14 programs)73 projects (14 programs)Approximately 90 TRC members Approximately 90 TRC members participatedparticipated

Approximately 145 OSEL staff Approximately 145 OSEL staff are involvedare involved

72 TRC members from CDRH, 72 TRC members from CDRH, and the rest from CDER, CBER, and the rest from CDER, CBER, EPA, NIST, etc.EPA, NIST, etc.

4646

Critical Path Research Critical Path Research

Leverages basic science knowledgeLeverages basic science knowledge

Leverages cumulative research experiencesLeverages cumulative research experiences

Translational ResearchTranslational Research

Critical Path ResearchCritical Path Research

Basic Research

Basic Research

PrototypeDesign or Discovery

PrototypeDesign or Discovery

PreclinicalDevelopmentPreclinicalDevelopment

FDA Filing/Approval &

LaunchPreparation

FDA Filing/Approval &

LaunchPreparation

Clinical DevelopmentClinical Development

Does not Does not compromise compromise safety and safety and effectiveness effectiveness evaluationsevaluations

4747

Critical Path ResearchCritical Path Research

UpdateUpdate

We have reviewed and compiled all of the We have reviewed and compiled all of the comments received on the public docketcomments received on the public docket

– Critical Path Public DocketCritical Path Public Docket

Solicited thoughts on areas benefit from research Solicited thoughts on areas benefit from research and development of critical path evaluative toolsand development of critical path evaluative tools

We are nearing completion the National We are nearing completion the National Critical Paths Opportunities ListCritical Paths Opportunities List

4848

Organizational ScorecardsOrganizational Scorecards


Update Center scorecards, includes Update Center scorecards, includes implementing Quality review implementing Quality review Assessment metricsAssessment metrics

Develop a pilot automated scorecard Develop a pilot automated scorecard tool tool

Scorecards help manage organizational Scorecards help manage organizational performance in CDRH strategic areasperformance in CDRH strategic areas

Scorecards help manage organizational Scorecards help manage organizational performance in CDRH strategic areasperformance in CDRH strategic areas

4949

Project Management PlansProject Management Plans


Effectively manage long term projects Effectively manage long term projects and new initiativesand new initiatives– Project milestonesProject milestones

– Resource requirementsResource requirements

– Quarterly reportsQuarterly reports

5050

Improving InfrastructureImproving InfrastructureWhite OakWhite Oak

Life Sciences building Life Sciences building opened Dec. 2003opened Dec. 2003

Shared between CDRH Shared between CDRH and CDERand CDER

Considerable progress Considerable progress on the CDER Office on the CDER Office building and the Award-building and the Award-winning Shared Use winning Shared Use buildingbuilding

Engineering and Engineering and Physics buildingPhysics building

100% design100% design

Expected occupancy Expected occupancy Spring 2006Spring 2006

5151

Working Towards Working Towards Meeting Meeting

Performance GoalsPerformance Goals

5252

Scientific ReviewScientific Review


Interactive RevInteractive Rev

Original PMA MilestonesOriginal PMA Milestones

Filing ReviewFiling Review

Panel PlanningPanel Planning

Closeout ReviewCloseout Review

PMA Received

Panel Go/No GoPanel Go/No Go

Panel MeetingPanel Meeting

Filing LetterFiling Letter

Final DecisionFinal Decision

320 days

Major

Deficiency

Letter

Clock Clock

StopsStops

Clock Clock

StopsStops

Status LetterStatus LetterConsults CompleteConsults Complete

2-cycle scenario2-cycle scenario

5353

Original PMA MilestonesOriginal PMA Milestones

Filing ReviewFiling Review


Panel PlanningPanel Planning

Closeout Review

PMA ReceivedPMA Received

Final DecisionFinal Decision

180 days

Status LetterStatus LetterConsults

Complete

ConsultsComplete

Interactive ReviewInteractive Review

1-cycle scenario1-cycle scenario

Panel Go/No GoPanel Go/No Go

Filing LetterFiling Letter

Panel MeetingPanel Meeting

5454

MDUFMA Performance Goals MDUFMA Performance Goals

Performance Measured atPerformance Measured atFY 2003 CohortFY 2003 Cohort

Goal: None Goal: None until FY 2006until FY 2006

FY 2004 CohortFY 2004 Cohort



Goal: None until Goal: None until FY 2006FY 2006

3 months into FY3 months into FY 88.9%88.9% 100.0%100.0% ——

6 months into FY6 months into FY 93.3%93.3% 100.0%100.0%


End of FY (12 months)End of FY (12 months) 97.4%97.4% 100.0%100.0%

15 months after start of FY15 months after start of FY 97.4%97.4% 100.0%100.0%

18 months after start of FY18 months after start of FY 97.6%97.6%




Remaining to close cohortRemaining to close cohort 5 (of 47)5 (of 47) 25 (of 47)25 (of 47) TBDTBD

PMAs and Panel-track SupplementsPMAs and Panel-track Supplements FDA Decisions within 320 DaysFDA Decisions within 320 Days

PMAs and Panel-track SupplementsPMAs and Panel-track Supplements FDA Decisions within 320 DaysFDA Decisions within 320 Days

5555

Performance Measured atPerformance Measured at FY 2003 CohortFY 2003 Cohort





Goal: 75%Goal: 75%

3 months into FY3 months into FY 100.0%100.0% —— ——





18 months after start of FY18 months after start of FY 84.0% 84.0%




Remaining to close cohortRemaining to close cohort —— ≤ ≤ 55 TBDTBD

PMAs and Panel-track SupplementsPMAs and Panel-track SupplementsFirst Action = “Major Deficiency” Letter within 150 DaysFirst Action = “Major Deficiency” Letter within 150 DaysPMAs and Panel-track SupplementsPMAs and Panel-track SupplementsFirst Action = “Major Deficiency” Letter within 150 DaysFirst Action = “Major Deficiency” Letter within 150 Days

MDUFMA Performance GoalsMDUFMA Performance Goals

5656


Performance Measured at0Performance Measured at0FY 2003 CohortFY 2003 Cohort





Goal: 80%Goal: 80%

3 months into FY3 months into FY 87.7%87.7% 86.4%86.4% 100.0%100.0%









Remaining to close cohortRemaining to close cohort — — (of 203)(of 203) 18 (of 103)18 (of 103) TBDTBD

180-day Supplements180-day SupplementsFDA Decisions within 180 DaysFDA Decisions within 180 Days

180-day Supplements180-day SupplementsFDA Decisions within 180 DaysFDA Decisions within 180 Days

5757






Goal: 80%Goal: 80%

3 months into FY3 months into FY —— —— 100.0%100.0%









Remaining to close cohortRemaining to close cohort —— ≤ ≤ 1616 TBDTBD

180-day Supplements180-day SupplementsFirst Action = “Not Approvable” Letter within 120 DaysFirst Action = “Not Approvable” Letter within 120 Days

180-day Supplements180-day SupplementsFirst Action = “Not Approvable” Letter within 120 DaysFirst Action = “Not Approvable” Letter within 120 Days


5858







Goal: 75%Goal: 75%










Remaining to close cohortRemaining to close cohort 25 (of 3,752)25 (of 3,752) 376 (of 3,411)376 (of 3,411) TBDTBD

510(k)s510(k)sSE, NSE Decisions within 90 DaysSE, NSE Decisions within 90 Days

510(k)s510(k)sSE, NSE Decisions within 90 DaysSE, NSE Decisions within 90 Days

5959






Goal: 70%Goal: 70%










Remaining to close cohortRemaining to close cohort ≤ ≤ 2525 ≤ ≤ 376376 TBDTBD

510(k)s510(k)sFirst Action = “Additional Information” Letter within 75 DaysFirst Action = “Additional Information” Letter within 75 Days

510(k)s510(k)sFirst Action = “Additional Information” Letter within 75 DaysFirst Action = “Additional Information” Letter within 75 Days


6060

Assuring Assuring Postmarket Postmarket Medical Device SafetyMedical Device Safety

FDA FDA under scrutinyunder scrutiny

Identifying adverse events so rare or that occur under Identifying adverse events so rare or that occur under specific conditionsspecific conditions

Identifying adverse events so rare or that occur under Identifying adverse events so rare or that occur under specific conditionsspecific conditions

6161

New Claims Add To Data That Put Vioxx Drug On Hot Seat

New Vioxx, Celebrex Studies Show Mixed Results

FDA panel votes to allow Vioxx back on

market

FDA Issues Public Health Advisory on Vioxx as its Manufacturer Voluntarily Withdraws the Product

A Reminder That No Drug Is Risk-Free

F.D.A. Panel Says Pain Relievers Should Remain on Market

FDA opens hearing on safety of arthritis drugs

http://online.wsj.com/home

http://www.timesonline.co.uk/

http://www.heraldextra.com/index.php

6262

Boston Scientific Stent Recall Grows to 96K Units

FDA Is Reviewing Reports of Trouble With

Taxus Stent Boston Scientific's Older Stents

Draw Scrutiny of FDA

Boston Scientific Expands Recall of Troubled Stent

FDA won't expand recall of stents

FDA Temperature up over Cordis

Drug-coated stents may face additional FDA scrutiny

FDA Advises Physicians of Adverse Events Associated with Cordis Cypher Coronary Stents

http://online.wsj.com/home

6363

0

500

1000

1500

2000

2500

3000

3500

FY96 FY97 FY98 FY99 FY00 FY01 FY02 FY03

Domestic

Foreign

Device GMP/QS Inspection TrendsDevice GMP/QS Inspection Trends

Statutory Requirement

6464

Links Between Process (GMP)

Risks and Patient Risks are Lost

Links Between Process (GMP)

Risks and Patient Risks are Lost

Risk-based InspectionsRisk-based Inspections

RISK

Pro

ce

ss

es

In

sp

ec

tio

n R

isk

cGMP

RISK

Qu

ali

ty P

ati

en

t)

Fa

cto

rs

Patient

Correlation?

RISK

Pro

ce

ss

es

In

sp

ec

tio

n R

isk

RISK

Qu

ali

ty (

Pa

tie

nt)

F

ac

tors

GMP Patient

GoalGoalPrioritize Actions on

GMP Risks Correlating to Patient

Risks

GoalGoalPrioritize Actions on

GMP Risks Correlating to Patient

Risks

6565

Third Party Inspection ProgramThird Party Inspection Program

Inspections of eligible manufacturers of Inspections of eligible manufacturers of Class II and Class III medical devices by Class II and Class III medical devices by accredited personsaccredited persons

Inspections by accredited persons Inspections by accredited persons conducted in essentially the same manner as conducted in essentially the same manner as those conducted by FDAthose conducted by FDA

Inspections by accredited persons Inspections by accredited persons conducted independent of third party conducted independent of third party inspections performed under the U.S./EC inspections performed under the U.S./EC Mutual Recognition Agreement (MRA)Mutual Recognition Agreement (MRA)

6666

Third Party Inspection ProgramThird Party Inspection Program

UpdateUpdate

Implemented MDUFMA authority to accredit Implemented MDUFMA authority to accredit third partiesthird parties

Issued guidance Issued guidance

Published criteria for accredited persons Published criteria for accredited persons

Selected 15 third parties to participate in the Selected 15 third parties to participate in the program program

6767

Achieving Achieving Pre/Postmarket Pre/Postmarket

BalanceBalance

6868

A start, not a cure, for FDA

FDA to create drug safety boardIndependent panel to monitor medicines once they're on market

F.D.A. Moves Toward More Openness With the Public

FDA to Institute Safety BoardThe goal is to more quickly identify problems with drugs and to issue alerts. The agency has been under growing pressure to act.

http://www.cnn.com/

http://www.chicagotribune.com/

Building Better Reporting SystemsBuilding Better Reporting SystemsAdverse Event Reporting SystemAdverse Event Reporting System

Voluntary reporting since 1973 (3%)Voluntary reporting since 1973 (3%)Mandatory reporting Mandatory reporting

Since 1984 - manufacturers (93%) and Importers (1%) Since 1984 - manufacturers (93%) and Importers (1%) Since 1990 - user facilities (3%)Since 1990 - user facilities (3%)

125,000 reports/year; 1.25 million total125,000 reports/year; 1.25 million total

MandatoryMandatoryReportingReporting

FDAFDA VoluntaryVoluntaryReportingReporting

Product ProblemsProduct Problems

Clinical ProblemsClinical Problems

7070

Building Better Reporting SystemsBuilding Better Reporting Systems Medical Device Reporting (MDR)Medical Device Reporting (MDR)

Expedite analysis of reported serious injuriesExpedite analysis of reported serious injuriesImplement Phase 1 of Implement Phase 1 of eMDReMDR Timely access, review and action on available Timely access, review and action on available and new reportsand new reports

FY 04 UpdateFY 04 Update

57,600 reports from manufacturers, user 57,600 reports from manufacturers, user facilities, and importers facilities, and importers

3887 voluntary reports from health care 3887 voluntary reports from health care professionals and the publicprofessionals and the public

7171

Building Better Reporting SystemsBuilding Better Reporting Systems MedSun and LabSunMedSun and LabSun

The Medical Product Surveillance Network (MedSun) is The Medical Product Surveillance Network (MedSun) is an interactive, internet-based reporting program.an interactive, internet-based reporting program.

The Medical Product Surveillance Network (MedSun) is The Medical Product Surveillance Network (MedSun) is an interactive, internet-based reporting program.an interactive, internet-based reporting program.

Continue recruitment of reporting facilitiesContinue recruitment of reporting facilities

FY 04 Update: 299 facilities nationwideFY 04 Update: 299 facilities nationwide

FY 05 Target: 350 facilities nationwideFY 05 Target: 350 facilities nationwide

Target reports from laboratories (pathology Target reports from laboratories (pathology and in vitro diagnostic tests) in the reporting and in vitro diagnostic tests) in the reporting hospitals (LabSun)hospitals (LabSun)

Increase reporting from hospital laboratoriesIncrease reporting from hospital laboratories

7272

Condition of Approval (CoA) StudiesCondition of Approval (CoA) Studies

Transfer tracking and follow-up to Transfer tracking and follow-up to postmarket postmarket

Develop tracking systemDevelop tracking system

Involve epidemiology staff in PMA reviewInvolve epidemiology staff in PMA review

Develop postmarket plan (identify products Develop postmarket plan (identify products risk)risk)

Postmarket studies designed to address Postmarket studies designed to address postmarket questionspostmarket questions

Prompt follow-up with sponsors when Prompt follow-up with sponsors when requirements not being met requirements not being met

7373

Condition of Approval (CoA) StudiesCondition of Approval (CoA) Studies

Feedback and interaction with sponsor as Feedback and interaction with sponsor as CoA study progressesCoA study progresses

Public availability of study status on Agency Public availability of study status on Agency websitewebsite

Panel feedback with updates, industry or Panel feedback with updates, industry or CDRHCDRH

Mandate postmarket study if neededMandate postmarket study if needed

7474

Communicating Medical TechnologyCommunicating Medical Technology

As new technology emerges, it is not only As new technology emerges, it is not only

our responsibility to assure its safety and our responsibility to assure its safety and

effectiveness, but also to communicate effectiveness, but also to communicate

its existence and usefulness to the public its existence and usefulness to the public

at large.at large.

As new technology emerges, it is not only As new technology emerges, it is not only

our responsibility to assure its safety and our responsibility to assure its safety and

effectiveness, but also to communicate effectiveness, but also to communicate

its existence and usefulness to the public its existence and usefulness to the public

at large.at large.

7575

Educating Healthcare Providers and Educating Healthcare Providers and Protecting Consumers through InformationProtecting Consumers through Information

Safety AlertsSafety Alerts

Public Health Public Health NotificationsNotifications

Labeling ChangesLabeling Changes

Scientific Scientific PublicationsPublications

FDA Patient Safety FDA Patient Safety NewsNews

Patient Safety PortalPatient Safety Portal

Recalls and Other Recalls and Other Regulatory ActionsRegulatory Actions

7676

Protecting Consumers through Protecting Consumers through InformationInformation

CDRH Disease and Product- specific CDRH Disease and Product- specific WebsitesWebsites

Diabetes Information Diabetes Information www.fda.gov/diabeteswww.fda.gov/diabetes

HeartHealth Online HeartHealth Online www.fda.goc/hearthealthwww.fda.goc/hearthealth

LASIK www.fda.gov/cdrh/lasikLASIK www.fda.gov/cdrh/lasik

Whole-Body Scanning Using CT Whole-Body Scanning Using CT www.fda.gov/cdrh/ctwww.fda.gov/cdrh/ct

Cochlear Implants Cochlear Implants www.fda.gov/cdrh/cochlearwww.fda.gov/cdrh/cochlear

7777

Educating Healthcare Providers and Educating Healthcare Providers and ConsumersConsumers

Communicating the existence and usefulness of Communicating the existence and usefulness of new technologiesnew technologies

One Pagers – New Device Approvals One Pagers – New Device Approvals www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopiwww.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/mda/mda-list.cfm?list+1c/mda/mda-list.cfm?list+1

Utilizing the internet in various ways to promote Utilizing the internet in various ways to promote communication and educationcommunication and education

ListServes – Breast Implants ListServes – Breast Implants www.fda.gov/cdrh/biclwww.fda.gov/cdrh/bicl

7878

Providing Industry AssistanceProviding Industry Assistance

Division of Small Manufacturers, International, Division of Small Manufacturers, International, and Consumer Assistance and Consumer Assistance

Phone: 800-638-2041 or 301-443-6597Phone: 800-638-2041 or 301-443-6597

Email: Email: [email protected]@cdrh.fda.gov

Website www.fda.gov/cdrhWebsite www.fda.gov/cdrh

Educational ProgramsEducational Programs

GuidanceGuidance

TeleconferencesTeleconferences

LabelingLabeling

Human FactorsHuman Factors

7979

Facilitating Technology and InnovationFacilitating Technology and InnovationTechnology and Technology and

Innovation Innovation ChallengesChallenges

Role of FDARole of FDA Meeting the ChallengeMeeting the Challenge

Accelerated Accelerated Pace of Pace of Technology and Technology and InnovationInnovation

Complexity of Complexity of New TechnologyNew Technology

Establishing safety and Establishing safety and effectiveness of complex effectiveness of complex technologies faster and technologies faster and cost-effectivelycost-effectively

Assuring postmarket Assuring postmarket medical device safety by medical device safety by identifying adverse identifying adverse events so rare or that events so rare or that occur under specific occur under specific conditionsconditions

Communicating medical Communicating medical device existence and device existence and usefulness to the publicusefulness to the public

CDRH Strategic PlanningCDRH Strategic Planning

Meeting MDUFMA GoalsMeeting MDUFMA Goals

Strengthening our Strengthening our workforce for the 21st workforce for the 21st centurycentury

Enhancing knowledge Enhancing knowledge managementmanagement

Achieving pre/postmarket Achieving pre/postmarket balance balance

Conducting business in Conducting business in an open and transparent an open and transparent mannermanner

1 cdrh update facilitating medical device innovation and technology dan schultz, md director, center...

Documents

innovation slide

medical imaging slide

home slide

anthrax slide

year slide

new medical technology

medical device innovation

university of michigan