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?