premarket review performance goals donna-bea tillman director, office of device evaluation director,...
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Premarket Review Premarket Review Performance GoalsPerformance Goals
Donna-Bea TillmanDonna-Bea Tillman Director, Office of Device EvaluationDirector, Office of Device Evaluation
Don St. PierreDon St. PierreDeputy Director, Office of In Vitro Deputy Director, Office of In Vitro
Diagnostic Device Evaluation and SafetyDiagnostic Device Evaluation and Safety
MDUFMA Stakeholder MeetingMDUFMA Stakeholder MeetingNovember 18, 2004
MDUFMA’s PromiseMDUFMA’s Promise
FDA will turn FDA will turn dollars into dollars into shorter review shorter review times.times.
Meeting the Meeting the MDUFMA goals MDUFMA goals while while maintaining maintaining our our commitment to commitment to good science.good science.
MDUFMA’s ChallengeMDUFMA’s Challenge
How are we How are we making this making this happen?happen?
Office of Office of Device Device
EvaluationEvaluation
Office ofOffice of
Surveillance Surveillance & Biometrics& Biometrics
Office of Office of Science & Science &
Engineering Engineering LaboratoriesLaboratories
Office Office of of
ComplianceCompliance
Office of Office of Communication, Communication, Education, and Education, and
Radiation Radiation ProgramsPrograms
Office of In Vitro Office of In Vitro Diagnostic Device Diagnostic Device
Evaluation and Evaluation and SafetySafety
Office of Office of Management Management OperationsOperations
New Vision of Pre-Market ReviewNew Vision of Pre-Market Review
What are we doing to foster this What are we doing to foster this vision?vision?
Shared hiresShared hires eRoomeRoom eConsultseConsults Shared agreement Shared agreement
on timelines…..on timelines…..
-> Shared commitment to the goals
How are we How are we spending your spending your
money?money?
Hiring!Hiring!
575534529 660
735681675
827
0
100
200
300
400
500
600
700
800
900
FY 02 FY 03 FY 04 FY 05Projection
Light Blue -- Other MDUFMA Review Process FTEs: Adverse Exp. Reporting,Lab Based Studies, Problem ID Resolution, Science Based Training, Domestic Standards, and Postmarket Studies.
Red -- Premarket FTEs: Application Review, Guidance and Standards, Bioresearch monitoring and Manufacturers assistance.
CDRH Device Review Process CDRH Device Review Process FTEsFTEs
0
5
10
15
20
25
30
35
40
45
50
MedicalOfficers
Engineers Scientists ProjectManagers
ProgramSupport
CSOs Statistician Attorney
FY 04
FY 03
9
28
45
812 12 15
1
CDRH Device Review FTEs by CDRH Device Review FTEs by CategoryCategory
Physicians* - 15Physicians* - 15 Visiting Scholar – senior level clinicians, surgeonsVisiting Scholar – senior level clinicians, surgeons Fellow - physician during fellowship trainingFellow - physician during fellowship training Resident – physician during residency trainingResident – physician during residency training
Engineers* - 42Engineers* - 42 Visiting Scholar – senior level engineerVisiting Scholar – senior level engineer Co-op studentsCo-op students InternsInterns
Physicists* - 2Physicists* - 2 Scientists* - 5Scientists* - 5
*includes students*includes students
Medical Device Fellowship Medical Device Fellowship Program (FY04)Program (FY04)
All those new hires need to be trainedAll those new hires need to be trained The good news: training for new recruits The good news: training for new recruits
improved their proficiencyimproved their proficiency The bad news: training for new recruits The bad news: training for new recruits
took a lot of resources and is not took a lot of resources and is not complete. complete.
We also need to maintain the skills of We also need to maintain the skills of existing staffexisting staff
Training!Training!
Improved IT infrastructure!Improved IT infrastructure! Current IT needsCurrent IT needs
TrackingTracking ReviewingReviewing CollaboratingCollaborating Managing correspondenceManaging correspondence Archiving - ImageArchiving - Image Electronic
Review?
And maybe one day….And maybe one day….
Just the Just the NumbersNumbers
For complete report, please see:http://www.fda.gov/cdrh/mdufma/presentations/102004-kahan.ppt
0
100
200
300
400
FD
A D
ays
0
100
200
300
400
FD
A D
ay
sStatus of FY03 PMA/O & PT-PMA/S Status of FY03 PMA/O & PT-PMA/S
receipt cohort receipt cohort
Complete
In Process
(August 18, 2004)
100% of those with final decisions
completed in < 320 days
In Process
Complete
CDRHCDRHPMA PerformancePMA Performance
FY 2003 Receipt Cohort as of 9/30/2004FY 2003 Receipt Cohort as of 9/30/2004
47 Original PMAs and P-T Supplements filed 47 Original PMAs and P-T Supplements filed 41 FDA decisions; 6 pending applications41 FDA decisions; 6 pending applications
% of decisions meeting goal: 95%% of decisions meeting goal: 95% % of cohort meeting goal (to date): 83% % of cohort meeting goal (to date): 83% % awaiting MDUFMA decision: 13%% awaiting MDUFMA decision: 13%
FY 2006 Goal: 80% of FDA decisions within 320 FDA daysFY 2006 Goal: 80% of FDA decisions within 320 FDA days (Decision = approval, approvable, approvable pending GMP, not approvable, (Decision = approval, approvable, approvable pending GMP, not approvable,
denial)denial)
CDRHCDRHPMA PerformancePMA Performance
FY 2003 Receipt Cohort as of FY 2003 Receipt Cohort as of 9/30/20049/30/2004
25 125 1stst action = major deficiency letter action = major deficiency letter
% of actions meeting goal: 84%% of actions meeting goal: 84%FY 2005 Goal: 75% within 150 FDA daysFY 2005 Goal: 75% within 150 FDA days
22 “all other” 122 “all other” 1stst actions actions
% actions meeting goal: 96%% actions meeting goal: 96%FY 2005 Goal: 75% 180 FDA daysFY 2005 Goal: 75% 180 FDA days
FY 2003 first action cohort is FY 2003 first action cohort is closedclosed
0
100
200
300
FD
A D
ays
0
50
100
150
200
FD
A D
ays
Status of FY04 PMA/O & PT-PMA/S Status of FY04 PMA/O & PT-PMA/S receipt cohortreceipt cohort
Complete
In Process
(August 18, 2004)
100% of those with final decisions completed in <
320 days
In ProcessComplete
CDRHCDRHPMA PerformancePMA Performance
FY 2004 Receipt Cohort as of 9/30/2004FY 2004 Receipt Cohort as of 9/30/2004
41 Original PMAs and P-T Supplements filed 41 Original PMAs and P-T Supplements filed 11 FDA decisions; 30 pending applications11 FDA decisions; 30 pending applications
% of decisions meeting goal: 100%% of decisions meeting goal: 100% % of cohort meeting goal (to date): 27% % of cohort meeting goal (to date): 27% % awaiting MDUFMA decision: 73%% awaiting MDUFMA decision: 73%
FY 2006 Goal: 80% of FDA decisions within 320 FDA daysFY 2006 Goal: 80% of FDA decisions within 320 FDA days (Decision = approval, approvable, approvable pending GMP, not approvable, (Decision = approval, approvable, approvable pending GMP, not approvable,
denial)denial)
CDRHCDRHPMA PerformancePMA Performance
FY 2004 Receipt Cohort as of FY 2004 Receipt Cohort as of 9/30/20049/30/2004
20 120 1stst action = major deficiency letter action = major deficiency letter
% of actions meeting goal: 85%% of actions meeting goal: 85%FY 2005 Goal: 75% within 150 FDA daysFY 2005 Goal: 75% within 150 FDA days
12 “all other” 112 “all other” 1stst actions actions
% actions meeting goal: 100%% actions meeting goal: 100%FY 2005 Goal: 75% 180 FDA daysFY 2005 Goal: 75% 180 FDA days
9 with first action pending (22% of 9 with first action pending (22% of cohort)cohort)
Improving PMA performanceImproving PMA performance
Goal: Shorten Goal: Shorten both cycle and both cycle and total decision total decision timestimes
… … which will improve which will improve predictability and predictability and decrease time-to-decrease time-to-market.market.
Original PMA Milestones:Original PMA Milestones:1-cycle Scenario1-cycle Scenario
Filing Review
Scientific Review
Panel Planning
Closeout Review
PMA Received`
Panel Go/NoGo
Panel Meeting
Filing Letter
Final Decision
180 days
StatusLetter
Consults Complete
Interactive Review
Original PMA Milestones:Original PMA Milestones:2-cycle Scenario2-cycle Scenario
Filing Rev
Scientific Review
Panel Planning
Closeout Review
PMA Received
Panel Go/NoGo
Panel Meeting
Filing Letter
Final Decision
320 days
Major Def.
Letter
Scientific Review
Clock Stops
Staus Letter
Interactive Review
Consults Complete
510k Goals510k Goals
FY03 510k PerformanceFY03 510k PerformanceFY03 FY03 PerformancePerformance
FY05 GoalFY05 Goal
Final Final decision decision <90 days<90 days
76%76% 75%75%
First action First action <75 days<75 days
58%58% 70%70%
Second Second action < 60 action < 60 daysdays
50%50% 70%70%
Need to improve performance on cycle goals
Meeting the MDUFMA goals: Meeting the MDUFMA goals: Review Process for Traditional 510ksReview Process for Traditional 510ks
Preliminary determination that no significant additional info
needed
FDA Initial Review Interactive ReviewFinal
Decision (<90 total
days)
Scenario #1
Meeting the MDUFMA goals: Meeting the MDUFMA goals: Review Process for Traditional 510ksReview Process for Traditional 510ks
FDA Initial Review Interactive Review
Determination that significant additional
info needed
Hold
Final Decision (<90 total
days)
Scenario #2
Preliminary determination that no significant
additional info needed
Meeting the MDUFMA goals: Meeting the MDUFMA goals: Review Process for Traditional 510ksReview Process for Traditional 510ks
FDA Initial Review Review
Determination that significant additional
info needed
Hold
Final Decision (<90 total
days)
Scenario #3
Hold Review
Determination that significant additional
info needed
Preliminary FY04 510k Preliminary FY04 510k PerformancePerformance
FY04 FY04 PerformancePerformance
FY05 GoalFY05 Goal
Final Final decision decision <90 days<90 days
89%89% 75%75%
First action First action <75 days<75 days
78%78% 70%70%
Second Second action < 60 action < 60 daysdays
81%81% 70%70%
Preliminary data suggests improvement in performance on cycle goals
29% of cohort awaiting final decision as of 9/30/04
What about the What about the Science?Science?
Program to Assess Quality of Program to Assess Quality of Premarket ReviewsPremarket Reviews
Focuses on selected cross-cutting Focuses on selected cross-cutting areas (e.g., biocompatibility)areas (e.g., biocompatibility)
Retrospective (post-decision) peer Retrospective (post-decision) peer assessments of sampled reviewsassessments of sampled reviews
Quality assessment teams with Quality assessment teams with defined criteriadefined criteria
Pilot underwayPilot underway
Where have we been?Where have we been?
We’ve made We’ve made progress in progress in meeting the meeting the goals, but it has goals, but it has come at a come at a price.price.
The price of early successThe price of early success
Our staff are working at the Our staff are working at the limits of their abilitieslimits of their abilities
““Luxuries” such as training, Luxuries” such as training, standards, and guidance standards, and guidance development have been development have been neglectedneglected
Where are we now?Where are we now?
We’ll continue We’ll continue to improve to improve performance, performance, but there are but there are additional additional challenges challenges ahead.ahead.
The number of combination The number of combination products is growing…products is growing…
Coronary Coronary StentStent
Pacing Pacing LeadLead
Bone graftBone graft… … necessitating new kinds necessitating new kinds of technical expertise and of technical expertise and new regulatory new regulatory paradigms.paradigms.
The number of 510ks with The number of 510ks with clinical data is growing…clinical data is growing…
Embolic protection Embolic protection devicesdevices
… … requiring more in-depth requiring more in-depth review, including review, including occasional Panel input.occasional Panel input.
Vascular anastomsis
devices for CABG
Image-guided Image-guided bronchoscopesbronchoscopes
Barbed suturesBarbed suturesGlaucoma shuntsGlaucoma shunts
Daily wear contact lenses
CPAP devices for apnea
The number of expedited The number of expedited submissions is growing….submissions is growing….
expedited PMAs in FYO4expedited PMAs in FYO4
vs.vs.3 expedited PMAs in FYO33 expedited PMAs in FYO3
1414
… … shortening timeframes shortening timeframes and bringing increasingly and bringing increasingly complex scientific complex scientific questions.questions.
Where are we going?Where are we going?
The best is The best is yet to yet to come!come!
Systematic management of Systematic management of timeframestimeframes
Improvements to IT infrastructureImprovements to IT infrastructure Well-trained staffWell-trained staff More guidance documentsMore guidance documents Open communicationOpen communication
Strategies for Meeting Strategies for Meeting BeatingBeating the MDUFMA Goals the MDUFMA Goals
The REAL promise of The REAL promise of MDUFMAMDUFMA
More interactionMore interaction Stronger scienceStronger science Greater predictabilityGreater predictability
Better public Better public healthhealth
……and a continuing commitment to and a continuing commitment to Least Burdensome PrinciplesLeast Burdensome Principles
Office of Office of In VitroIn Vitro Diagnostic Device Diagnostic Device Evaluation and Safety (OIVD)Evaluation and Safety (OIVD)
Turbo 510(k) PilotTurbo 510(k) Pilot Software/program development Software/program development
Pre-IDEs Pre-IDEs Number/interactions increasingNumber/interactions increasing
Decision SummariesDecision Summaries Public/information sharingPublic/information sharing
Webpage Re-design in processWebpage Re-design in process Based on your feedbackBased on your feedback
Internal training (challenging the status Internal training (challenging the status quo)quo) Stressing TPLC, Communication, CollaborationStressing TPLC, Communication, Collaboration
Office of Office of In VitroIn Vitro Diagnostic Device Diagnostic Device Evaluation and Safety (OIVD)Evaluation and Safety (OIVD)
Also, Proactive in:Also, Proactive in: Bioterrorism activities to improve Bioterrorism activities to improve
development and access to rapid development and access to rapid diagnosticsdiagnostics
CLIA improvements (including CLIA improvements (including development of waiver criteria, program development of waiver criteria, program development)development)
PharmacogenomicsPharmacogenomics
MDUFMA
Questions?
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