CDRH Update Facilitating Medical Device Innovation and Technology

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CDRH UpdateFacilitating Medical Device
Innovation and Technology

• Dan Schultz, MD
• Director, Center for Devices and Radiological
  Health
• Food and Drug Administration
• Sixth Annual National Forum on Biomedical Imaging
  in Oncology
• Bethesda, MD
• April 7, 2005

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What is a Device?
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A Computer That Helps You Hear
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Miniaturized DevicesElectrical Stimulators

• Pacemakers

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Smart Drug Delivery Devices
Information-Rich Therapeutics
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Combination ProductsDrug-Eluting Stents

• Components
• Stent Platform Delivery System
• Carrier(s)
• Drug

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Intelligent DevicesStent as a Radiofrequency
Identifier

• Preclinical Model of Self Monitoring Stent
• Applications detect restenosis
• Measure blood pressure continuously

Yogesh Gianchandani and his team at the
University of Michigan
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Minimally Invasive DevicesImage (MRI) Guided
Treatment (HiFU)
Information Rich Therapeutics Diagnostics and
Therapeutic Device Uses magnetic resonance image
(MRI) guided focused ultrasound to target and
destroy non-cancerous uterine fibroids
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Medical Imaging Devices
Digital Mammography Produces images using X-rays
instead of film
Image Analysis Software Aids in the detection of
lung nodules
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Technology for Special Populations

• Left Ventricular Assist Device for Pediatric Use

• Stair-Climbing Wheelchair

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Technology Designed for Home Use
A Defibrillator for the Home
Home Testing for HIV
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Point of Care Diagnosis and Therapy Devices

• Enhancement of point of care testing
• Enhanced portability of increasingly complex
  laboratory analysis
• Example A portable test has been approved by
  CBER for HIV
• CDRH expects other high risk technologies to
  follow

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Biological Medical DevicesGenomics

• Impact on Therapeutic Products
• New knowledge about disease
• Animal models
• Pharmacogenomics
• Identify responders
• Understand toxicity
• Clinical diagnosis
• Clinical treatment monitoring

Personalized Medicine
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Biological Medical DevicesBiotechnology
Revolution

• Microarray Technology
• Providing insight into patient factors allowing
  for personalized medicine
• Amplichip

Personalized Medicine
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Technology We Hope We Never Need Bioterrorism
Diagnostic Testing
QuickELISA Anthrax-Pa Kit The first rapid serum
antibody test for anthrax

• Bioterrorism Diagnostic Testing
• Testing for biological warfare agents including
  microbes and toxic chemicals
• Biosensor detectors
• Nucleic acid amplification

Challenge Studies using real clinical samples
may not be possible so flexible regulatory and
scientific alternatives are essential
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Technology and Innovation

• What are the challenges today
• for bringing new medical
• technology to market?
• Accelerated Pace of Technology and Innovation
• Complexity of New Technology

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The Accelerating Pace of Technology and
Innovation Advances in Medical Imaging
Traditional Lateral Skull Film
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The Accelerating Pace of Technology and
Innovation Advances in Medical Imaging
41 CT slices

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The Accelerating Pace of Technology and
Innovation Advances in Medical Imaging


3-D CT Imaging
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The Accelerating Pace of Technology and
Innovation Advances in Medical Imaging
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Medical Device Industry Growth
Number of Manufacturers by Year
Dun Bradstreet Medical Device Firm Data
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Sales Volume Growth
(Billions of Dollars)
Note No economic adjustment to dollar value
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The Complexity of New Technologies

• Devices are getting smaller
• Miniaturization, New Materials, Nanotechnology
• Devices are getting smarter and are providing
  more information
• Intelligent Devices
• Biotechnology Revolution
• Personalized Medicine
• Combination Products
• Information-Rich Therapeutics

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The Complexity of New Technologies

• Devices are becoming more convenient for the
  patient
• Home Use
• Minimally Invasive
• Point of Care Diagnostics
• Devices are responding to heighten homeland
  security
• Bioterrorism-Related Devices
• Devices are meeting the needs for special
  populations

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Technology and InnovationFDA Role

• Establish reasonable
• assurance of the safety and
• effectiveness of medical devices
• marketed in the U.S.

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Technology and InnovationCDRH Challenges

• Effectively Managing a Changing Workload
• Increasing number of expedited submissions,
  combinations products and submissions with
  clinical data
• New Kinds of Scientific Expertise
• Meeting MDUFMA Commitments
• Performance goals
• Third-party inspections
• Establishing a Premarket/Postmarket Balance
• Greater degree of scrutiny

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Medical Device Program
CDRH Types and Numbers of Submissions Received
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.
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These are the issues that we face everyday

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

a complex and comprehensive set of review
goals, becoming more aggressive each year.
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The number of expedited submissions is growing.
shortening timeframes and bringing
increasingly complex scientific questions

The number of combination products is growing
necessitating new kinds of technical expertise
and new regulatory paradigms
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The complexity and need for clinical data is
growing
Embolic protection devices
Daily wear contact lenses
Vascular anastomosis devices for CABG
CPAP devices for apnea
requiring more in-depth review, including
occasional Panel input
Barbed sutures
Glaucoma shunts
Image-guided bronchoscopes
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BioterrorismEmergency Measures

• Emergency Preparedness - Medical device emergency
  shortages database
• Bioterrorism Diagnostics and Testing - QuickELISA
  Anthrax-Pa Kit, the first rapid serum antibody
  test for anthrax
• ASTM F2401-04 - Standard Practice for Security
  Checkpoint Metal Detector Screening of Persons
  with Medical Devices

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Meeting Technology Innovation Challenges
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Meeting the Challenges of Technology and
Innovation

• Strategic planning helps us achieve our goals and
  establish a vision for the future
• Meeting MDUFMA Goals
• Strengthening our workforce for the 21st
  century
• Enhancing our knowledge management
• Achieving a better pre/postmarket regulatory
  balance

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CDRH FY 05
Mission 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) Mission 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) Mission 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) Mission 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) Mission 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 Impact Measure, assess, improve and communicate our impact on public health Magnet for Excellence Attract and retain a diverse work force to accomplish our public health mission CDRH Strategic Goals Knowledge Management Enhance use of information and communication systems to support TPLC TPLC Align CDRH programs to effectively manage the product life cycle
Meet MDUFMA performance goals Strengthen our workforce for the 21st century CDRH Priorities Enhance our knowledge management Achieve better pre/postmarket regulatory balance
Public Health Promotion Assess and improve time to market for medical devices Public Health Protection Assess and improve risk management, identifying and resolving public health hazards Workforce Excellence Attract, develop and retain a highly skilled and diverse workforce to advance our public health mission Scorecard Key Result Areas Knowledge Management Communicating with our stakeholders to meet public health challenges throughout the TPLC TPLC Effective Management in Accordance with TPLC Principles
FY 05 MDUFMA performance goals Quality system for application review Review consults CoA studies Risk -based inspections MedSun and LabSun Medical device reports (MDR) Emergency Measures Priority hiring Professional development External expertise (MDFP and other initiatives) Priority Initiatives Guidance/standards Targeted IT initiatives Infrastructure upgrades Turbo 510(k) eConsult Communicating medical technology OIVD Model Research prioritization Radiological Health Strategy GHTF Organizational scorecards Project 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
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Priority Hiring
Office Hired FY 03 Hired FY 04 Two Year Totals Total MDUFMA Hires (Shared)
Total 75 57 132 (18 Shared)
OC 10 7 17 (1 Shared)
ODE 29 15 44 (6 Shared)
OCR 4 2 6 (0 Shared)
OIVD 11 6 17 (0 Shared)
OSB 6 11 18 (1 Shared)
OSM/OCD 4 3 6 (0 Shared)
OSEL 11 13 24 (11 Shared)
FY 03 and FY 04 Hires (by Specialty)
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Professional Development

• Develop training programs
• Provide professional and career development
  opportunities
• Science Leadership Education Program (SLEP)
• Basic Science Education Program (BSEP)
• Develop competency models
• Science
• Management
• Business

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External Expertise
Medical Device Fellowship Program (MDFP)

• Premarket reviews and consults
• Human factors issues
• Analysis of device failure modes
• Standards and guidance development
• Statistical analyses

Since its inception, MDFP has sponsored over 100
fellows in the program www.fda.gov/cdrh/mdfp
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Guidance Development

• Create a list of high priority guidances
• Establish performance goals
• Develop tracking mechanisms
• Engage industry stakeholders in the early stages
  of guidance development

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Standards Development

• Recognition to have significant influence
  throughout the world
• Participation to work with national and
  international committees
• CDRH Standards Participation
• 38 development organizations
• 238 Liaison Reps 220 National Committees and 128
  International Committees
• 538 Standards Activities 365 National and 173
  Other Activities
• Utilization
• Standards utilization in recent device
  applications - 55

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Global Harmonization Task Force
Mission Encourage the convergence of medical
device regulatory practices worldwide where
possible, while ensuring the safety,
effectiveness, and quality of medical devices.

• Develop guidance documents on basic regulatory
  practices
• Continue participating in GHTF study groups
• Study Group 1 regulatory and premarket
  requirements
• Study Group 2 postmarket vigilance
• Study Group 3 quality systems
• Study Group 4 regulatory auditing of quality
  systems
• NEW Study Group 5 Clinical Evidence

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Quality Systems for Application Review

• Focus on selected cross-cutting areas
• e.g., biocompatibility
• Use retrospective (post-decision) peer
  assessments
• Assemble quality assessment teams
• Continue with pilot program

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IT Initiatives

• Premarket Review Modernization
• Postmarket Medical Device Reporting (eMDR)
• ODE and OC Tracking Systems

• Electronic Registration and Listing
• eConsult
• Image2000
• Turbo 510(k)

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IT Initiatives Image2000

• Scan outgoing 513g and reduce backlog
• Decrease original PMA scanning times
• Scanning 510(k) in real time
• Electronic copies to eliminate need for scanning

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IT Initiatives Turbo 510(k)

• Continue pilot eSubmission with industry
  volunteers
• Develop eLoader tool for reviewers, allowing copy
  and paste from eSubmission into external
  applications
• Develop eReview tool, a standard 510(k) review
  template

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Research Prioritization

• FY 05 Goals
• Continue using prioritization model
• FY 04 Update
• 73 projects (14 programs)
• Approximately 90 TRC members participated
• Approximately 145 OSEL staff are involved
• 72 TRC members from CDRH, and the rest from CDER,
  CBER, EPA, NIST, etc.

• Criteria For Rating Projects
• Regulatory need PMA and IDE activity
• Scientific gaps and technical competence leading
  edge products
• Public health impact mortality, morbidity,
  quality of life

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Critical Path Research

• Leverages basic science knowledge
• Leverages cumulative research experiences

Does not compromise safety and effectiveness
evaluations
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Critical Path Research

• Update
• We have reviewed and compiled all of the comments
  received on the public docket
• Critical Path Public Docket
• Solicited thoughts on areas benefit from
  research and development of critical path
  evaluative tools
• We are nearing completion the National Critical
  Paths Opportunities List

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Organizational Scorecards
Scorecards help manage organizational performance
in CDRH strategic areas

• FY 05 Goals
• Update Center scorecards, includes implementing
  Quality review Assessment metrics
• Develop a pilot automated scorecard tool

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Project Management Plans

• FY 05 Goals
• Effectively manage long term projects and new
  initiatives
• Project milestones
• Resource requirements
• Quarterly reports

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Improving InfrastructureWhite Oak

• Life Sciences building opened Dec. 2003
• Shared between CDRH and CDER
• Considerable progress on the CDER Office building
  and the Award-winning Shared Use building

• Engineering and Physics building
• 100 design
• Expected occupancy Spring 2006

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Working Towards Meeting Performance Goals
MDUFMA
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Original PMA Milestones
2-cycle scenario
320 days
PMA Received
Clock Stops
Filing Review
Filing Letter
Scientific Review
Scientific Review
Interactive Rev
Consults Complete
Panel Go/No Go
Status Letter
Panel Planning
Major Deficiency Letter
Panel Meeting
Closeout Review
Final Decision
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Original PMA Milestones
1-cycle scenario
180 days
PMA Received
Filing Review
Filing Letter
Scientific Review
Interactive Review
Consults Complete
Panel Go/No Go
Status Letter
Panel Planning
Panel Meeting
Closeout Review
Final Decision
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MDUFMA Performance Goals
PMAs and Panel-track Supplements FDA Decisions
within 320 Days
Performance Measured at FY 2003 Cohort Goal None until FY 2006 FY 2004 Cohort Goal None until FY 2006 FY 2005 Cohort Goal None until FY 2006
3 months into FY 88.9 100.0
6 months into FY 93.3 100.0
9 months into FY 96.6 100.0
End of FY (12 months) 97.4 100.0
15 months after start of FY 97.4 100.0
18 months after start of FY 97.6
21 months after start of FY 97.6
24 months after start of FY 95.1
27 months after start of FY 95.2
Remaining to close cohort 5 (of 47) 25 (of 47) TBD
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MDUFMA Performance Goals
PMAs and Panel-track SupplementsFirst Action
Major Deficiency Letter within 150 Days
Performance Measured at FY 2003 Cohort Goal None until FY 2005 FY 2004 Cohort Goal None until FY 2005 FY 2005 Cohort Goal 75
3 months into FY 100.0
6 months into FY 100.0 100.0
9 months into FY 100.0 84.6
End of FY (12 months) 100.0 85.0
15 months after start of FY 86.4 84.0
18 months after start of FY 84.0 ü
21 months after start of FY 84.0 ü
24 months after start of FY 84.0 ü
27 months after start of FY 84.0 ü
Remaining to close cohort 5 TBD
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MDUFMA Performance Goals
180-day SupplementsFDA Decisions within 180 Days
Performance Measured at0 FY 2003 Cohort Goal None until FY 2005 FY 2004 Cohort Goal None until FY 2005 FY 2005 Cohort Goal 80
3 months into FY 87.7 86.4 100.0
6 months into FY 86.3 89.2
9 months into FY 89.9 92.9
End of FY (12 months) 91.9 97.3
15 months after start of FY 93.6 97.6
18 months after start of FY 94.1
21 months after start of FY 94.6
24 months after start of FY 94.1 ü
27 months after start of FY 94.1 ü
Remaining to close cohort (of 203) 18 (of 103) TBD
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MDUFMA Performance Goals
180-day SupplementsFirst Action Not
Approvable Letter within 120 Days
Performance Measured at FY 2003 Cohort Goal None until FY 2005 FY 2004 Cohort Goal None until FY 2005 FY 2005 Cohort Goal 80
3 months into FY 100.0
6 months into FY 0.0 83.3
9 months into FY 9.1 80.0
End of FY (12 months) 14.3 87.5
15 months after start of FY 16.7 89.2
18 months after start of FY 16.1
21 months after start of FY 16.1
24 months after start of FY 16.1 ü
27 months after start of FY 16.1 ü
Remaining to close cohort 16 TBD
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MDUFMA Performance Goals
510(k)sSE, NSE Decisions within 90 Days
Performance Measured at FY 2003 Cohort Goal None until FY 2005 FY 2004 Cohort Goal None until FY 2005 FY 2005 Cohort Goal 75
3 months into FY 100.0 100.0 100.0
6 months into FY 96.1 95.6
9 months into FY 90.7 90.7
End of FY (12 months) 87.1 89.0
15 months after start of FY 83.7 87.3
18 months after start of FY 79.4
21 months after start of FY 77.3
24 months after start of FY 76.4
27 months after start of FY 76.0
Remaining to close cohort 25 (of 3,752) 376 (of 3,411) TBD
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MDUFMA Performance Goals
510(k)sFirst Action Additional Information
Letter within 75 Days
Performance Measured at FY 2003 Cohort Goal None until FY 2005 FY 2004 Cohort Goal None until FY 2005 FY 2005 Cohort Goal 70
3 months into FY 90.0 93.5 99.6
6 months into FY 66.2 74.4
9 months into FY 60.2 76.0
End of FY (12 months) 59.1 78.5
15 months after start of FY 57.9 78.4
18 months after start of FY 57.8
21 months after start of FY 57.9
24 months after start of FY 57.9
27 months after start of FY 57.9
Remaining to close cohort 25 376 TBD
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Assuring Postmarket Medical Device Safety

• FDA
• under scrutiny

Identifying adverse events so rare or that occur
under specific conditions
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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
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
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Drug-coated stents may face additional FDA
scrutiny
FDA Advises Physicians of Adverse Events
Associated with Cordis Cypher Coronary Stents
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Device GMP/QS Inspection Trends
Statutory Requirement
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Risk-based Inspections
cGMP
Patient
Links Between Process (GMP) Risks and Patient
Risks are Lost
Quality Patient) Factors
Processes Inspection Risk
Correlation?
RISK ?
RISK ?
GMP
Patient
GoalPrioritize Actions on GMP Risks Correlating
to Patient Risks
Processes Inspection Risk
Quality (Patient) Factors
RISK ?
RISK ?
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Third Party Inspection Program

• Inspections of eligible manufacturers of Class II
  and Class III medical devices by accredited
  persons
• Inspections by accredited persons conducted in
  essentially the same manner as those conducted by
  FDA
• Inspections by accredited persons conducted
  independent of third party inspections performed
  under the U.S./EC Mutual Recognition Agreement
  (MRA)

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Third Party Inspection Program

• Update
• Implemented MDUFMA authority to accredit third
  parties
• Issued guidance
• Published criteria for accredited persons
• Selected 15 third parties to participate in the
  program

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Achieving Pre/Postmarket Balance
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F.D.A. Moves Toward More Openness With the Public
FDA to create drug safety board Independent panel
to monitor medicines once they're on market
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.
A start, not a cure, for FDA
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Building Better Reporting SystemsAdverse Event
Reporting System
Product Problems
Voluntary Reporting
Mandatory Reporting
FDA
Clinical Problems

• Voluntary reporting since 1973 (3)
• Mandatory reporting
• Since 1984 - manufacturers (93) and Importers
  (1)
• Since 1990 - user facilities (3)
• 125,000 reports/year 1.25 million total

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Building Better Reporting Systems Medical Device
Reporting (MDR)

• Expedite analysis of reported serious injuries
• Implement Phase 1 of eMDR
• Timely access, review and action on available and
  new reports
• FY 04 Update
• 57,600 reports from manufacturers, user
  facilities, and importers
• 3887 voluntary reports from health care
  professionals and the public

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Building Better Reporting Systems MedSun and
LabSun
The Medical Product Surveillance Network
(MedSun) is an interactive, internet-based
reporting program.

• Continue recruitment of reporting facilities
• FY 04 Update 299 facilities nationwide
• FY 05 Target 350 facilities nationwide
• Target reports from laboratories (pathology and
  in vitro diagnostic tests) in the reporting
  hospitals (LabSun)
• Increase reporting from hospital laboratories

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Condition of Approval (CoA) Studies

• Transfer tracking and follow-up to postmarket
• Develop tracking system
• Involve epidemiology staff in PMA review
• Develop postmarket plan (identify products risk)
• Postmarket studies designed to address postmarket
  questions
• Prompt follow-up with sponsors when requirements
  not being met

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Condition of Approval (CoA) Studies

• Feedback and interaction with sponsor as CoA
  study progresses
• Public availability of study status on Agency
  website
• Panel feedback with updates, industry or CDRH
• Mandate postmarket study if needed

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Communicating Medical Technology

• As new technology emerges, it is not only our
  responsibility to assure its safety and
  effectiveness, but also to communicate its
  existence and usefulness to the public at large.

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Educating Healthcare Providers and Protecting
Consumers through Information

• Safety Alerts
• Public Health Notifications
• Labeling Changes
• Scientific Publications

• FDA Patient Safety News
• Patient Safety Portal
• Recalls and Other Regulatory Actions

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Protecting Consumers through Information

• CDRH Disease and Product- specific Websites
• Diabetes Information www.fda.gov/diabetes
• HeartHealth Online www.fda.goc/hearthealth
• LASIK www.fda.gov/cdrh/lasik
• Whole-Body Scanning Using CT www.fda.gov/cdrh/ct
• Cochlear Implants www.fda.gov/cdrh/cochlear

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Educating Healthcare Providers and Consumers

• Communicating the existence and usefulness of new
  technologies
• One Pagers New Device Approvals
  www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic
  /mda/mda-list.cfm?list1
• Utilizing the internet in various ways to promote
  communication and education
• ListServes Breast Implants www.fda.gov/cdrh/bicl
  

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Providing Industry Assistance

• Division of Small Manufacturers, International,
  and Consumer Assistance
• Phone [phone] or 301-443-6597
• Email DSMICA_at_cdrh.fda.gov
• Website www.fda.gov/cdrh
• Educational Programs
• Guidance
• Teleconferences
• Labeling
• Human Factors

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Facilitating Technology and Innovation
Technology and Innovation Challenges Role of FDA Meeting the Challenge
Accelerated Pace of Technology and Innovation Complexity of New Technology Establishing safety and effectiveness of complex technologies faster and cost-effectively Assuring postmarket medical device safety by identifying adverse events so rare or that occur under specific conditions Communicating medical device existence and usefulness to the public CDRH Strategic Planning Meeting MDUFMA Goals Strengthening our workforce for the 21st century Enhancing knowledge management Achieving pre/postmarket balance Conducting business in an open and transparent manner
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