Premarket Review Performance Goals

1
Premarket Review Performance Goals
MDUFMA Stakeholder Meeting November 18, 2004

• Donna-Bea Tillman
• Director, Office of Device Evaluation
• Don St. Pierre
• Deputy Director, Office of In Vitro Diagnostic
  Device Evaluation and Safety

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MDUFMAs Promise

• FDA will turn dollars into shorter review
  times.

3
MDUFMAs Challenge
Meeting the MDUFMA goals while maintaining
our commitment to good science.
4
How are we making this happen?
5
New Vision of Pre-Market Review
Office of In Vitro Diagnostic Device Evaluation
and Safety
Office of Device Evaluation
Office of Science Engineering Laboratories
Office of Surveillance Biometrics
Office of Communication, Education, and Radiation
Programs
Office of Management Operations
Office of Compliance
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What are we doing to foster this vision?

• Shared hires
• eRoom
• eConsults
• Shared agreement on timelines..

-gt Shared commitment to the goals
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How are we spending your money?
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Hiring!
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CDRH Device Review Process FTEs
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.
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CDRH Device Review FTEs by Category
45
28
12
12
15
9
8
1
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Medical Device Fellowship Program (FY04)

• Physicians - 15
• Visiting Scholar senior level clinicians,
  surgeons
• Fellow - physician during fellowship training
• Resident physician during residency training
• Engineers - 42
• Visiting Scholar senior level engineer
• Co-op students
• Interns
• Physicists - 2
• Scientists - 5
• includes students

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Training!

• All those new hires need to be trained
• The good news training for new recruits improved
  their proficiency
• The bad news training for new recruits took a
  lot of resources and is not complete.
• We also need to maintain the skills of existing
  staff

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Improved IT infrastructure!

• Current IT needs
• Tracking
• Reviewing
• Collaborating
• Managing correspondence
• Archiving - Image

Electronic Review?

• And maybe one day.

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Just the Numbers
For complete report, please see http//www.fda.go
v/cdrh/mdufma/presentations/102004-kahan.ppt
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Status of FY03 PMA/O PT-PMA/S receipt cohort
(August 18, 2004)
100 of those with final decisions completed in
lt 320 days
Complete
In Process
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CDRHPMA PerformanceFY 2003 Receipt Cohort as of
9/30/2004

• 47 Original PMAs and P-T Supplements filed
• 41 FDA decisions 6 pending applications
• of decisions meeting goal 95
• of cohort meeting goal (to date) 83
• awaiting MDUFMA decision 13
• FY 2006 Goal 80 of FDA decisions within 320
  FDA days
• (Decision approval, approvable, approvable
  pending GMP, not approvable, denial)

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CDRHPMA PerformanceFY 2003 Receipt Cohort as of
9/30/2004

• 25 1st action major deficiency letter
• of actions meeting goal 84
• FY 2005 Goal 75 within 150 FDA days
• 22 all other 1st actions
• actions meeting goal 96
• FY 2005 Goal 75 180 FDA days
• FY 2003 first action cohort is closed

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Status of FY04 PMA/O PT-PMA/S receipt cohort
(August 18, 2004)
100 of those with final decisions completed in lt
320 days
Complete
In Process
19
CDRHPMA PerformanceFY 2004 Receipt Cohort as of
9/30/2004

• 41 Original PMAs and P-T Supplements filed
• 11 FDA decisions 30 pending applications
• of decisions meeting goal 100
• of cohort meeting goal (to date) 27
• awaiting MDUFMA decision 73
• FY 2006 Goal 80 of FDA decisions within 320
  FDA days
• (Decision approval, approvable, approvable
  pending GMP, not approvable, denial)

20
CDRHPMA PerformanceFY 2004 Receipt Cohort as of
9/30/2004

• 20 1st action major deficiency letter
• of actions meeting goal 85
• FY 2005 Goal 75 within 150 FDA days
• 12 all other 1st actions
• actions meeting goal 100
• FY 2005 Goal 75 180 FDA days
• 9 with first action pending (22 of cohort)

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Improving PMA performance

• Goal Shorten both cycle and total decision times

which will improve predictability and decrease
time-to-market.
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Original PMA Milestones1-cycle Scenario
180 days
PMA Received
Filing Review
Filing Letter
Scientific Review
Interactive Review
Panel Go/NoGo
Status Letter
Consults Complete
Panel Planning
Panel Meeting
Closeout Review
Final Decision
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Original PMA Milestones2-cycle Scenario
320 days
PMA Received
Filing Rev
Clock Stops
Filing Letter
Scientific Review
Scientific Review
Interactive Review
Major Def. Letter
Consults Complete
Panel Go/NoGo
Staus Letter
Panel Planning
Panel Meeting
Closeout Review
Final Decision
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510k Goals
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FY03 510k Performance
FY03 Performance FY05 Goal
Final decision lt90 days 76 75
First action lt75 days 58 70
Second action lt 60 days 50 70
Need to improve performance on cycle goals
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Meeting the MDUFMA goals Review Process for
Traditional 510ks
Scenario 1
Final Decision (lt90 total days)
FDA Initial Review
Interactive Review
Preliminary determination that no significant
additional info needed
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Meeting the MDUFMA goals Review Process for
Traditional 510ks
Scenario 2
Final Decision (lt90 total days)
FDA Initial Review
Interactive Review
Hold
Determination that significant additional info
needed
Preliminary determination that no significant
additional info needed
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Meeting the MDUFMA goals Review Process for
Traditional 510ks
Scenario 3
Final Decision (lt90 total days)
FDA Initial Review
Hold
Hold
Review
Review
Determination that significant additional info
needed
Determination that significant additional info
needed
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Preliminary FY04 510k Performance
29 of cohort awaiting final decision as of
9/30/04
FY04 Performance FY05 Goal
Final decision lt90 days 89 75
First action lt75 days 78 70
Second action lt 60 days 81 70
Preliminary data suggests improvement in
performance on cycle goals
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What about the Science?
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Program to Assess Quality of Premarket Reviews

• Focuses on selected cross-cutting areas (e.g.,
  biocompatibility)
• Retrospective (post-decision) peer assessments of
  sampled reviews
• Quality assessment teams with defined criteria
• Pilot underway

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Where have we been?
Weve made progress in meeting the goals, but it
has come at a price.
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The price of early success

• Our staff are working at the limits of their
  abilities
• Luxuries such as training, standards, and
  guidance development have been neglected

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Where are we now?
Well continue to improve performance, but there
are additional challenges ahead.
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The number of combination products is growing
Drug-eluting
Coronary Stent
Steroid-eluting
Pacing Lead
rhBMP
necessitating new kinds of technical expertise
and new regulatory paradigms.
Bone graft
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The number of 510ks with clinical data is growing
Daily wear contact lenses
Embolic protection devices
CPAP devices for apnea
Vascular anastomsis devices for CABG
Barbed sutures
Glaucoma shunts
requiring more in-depth review, including
occasional Panel input.
Image-guided bronchoscopes
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The number of expedited submissions is growing.

• expedited PMAs in FYO4

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vs.
3 expedited PMAs in FYO3
shortening timeframes and bringing increasingly
complex scientific questions.
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Where are we going?
The best is yet to come!
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Strategies for Meeting Beating the MDUFMA Goals

• Systematic management of timeframes
• Improvements to IT infrastructure
• Well-trained staff
• More guidance documents
• Open communication

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The REAL promise of MDUFMA

• More interaction
• Stronger science
• Greater predictability
• Better public health

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and a continuing commitment to Least Burdensome
Principles
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Office of In Vitro Diagnostic Device Evaluation
and Safety (OIVD)

• Turbo 510(k) Pilot
• Software/program development
• Pre-IDEs
• Number/interactions increasing
• Decision Summaries
• Public/information sharing
• Webpage Re-design in process
• Based on your feedback
• Internal training (challenging the status quo)
• Stressing TPLC, Communication, Collaboration

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Office of In Vitro Diagnostic Device Evaluation
and Safety (OIVD)

• Also, Proactive in
• Bioterrorism activities to improve development
  and access to rapid diagnostics
• CLIA improvements (including development of
  waiver criteria, program development)
• Pharmacogenomics

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Questions?
MDUFMA