Presentation: Update on a New Office – The FDA perspective on IVDs

Steven Gutman, M.D.

[Powerpoint]

May 10, 2003

People

• New Commissioner -- Dr. McClellan
• Deputy Commissioner – Dr. Crawford
• Chief Counsel – Dan Troy
• Seasoned Center Director – Dr. Feigal

People

• Deputy Office Director -- Don St. Pierre
• Deputy Office Director – James Woods
• Deputy Division Directors -- Josie Bautista, Jean Cooper, Freddie Poole

People

• AD for Special Programs -- Joe Hackett
• Senior Analyst – Sousan Altaie
• Legal Advisor for Regulatory Affairs -- Terri Garvin (detail)

Workload

• 43 day cycle time
• Average of 1.27 cycles

Workload

• Review times variable
• High profile devices – HPV, quantitative HCV

Workload -- Drivers

• Least Burdensome
• User Fees
• Good times/ better times

Key Players

• Secretary
• Commissioner
• Center Director
• Scorecards
• Business orientation

Strategic Plan -- Goals

• Mission related
• Total Product Life Cycle -- cradle to grave seamless oversight
• Knowledge Management

IVD Program

• Early 2002 -- Lillian Gill working group
• New organizational structure
• No hidden agendas
• Not unique endeavor

Intellectual Appeal

• Premarket review limitation
• Outdated law
• Snapshot approach
• Impact of scale-up
• Impact of wide-use

Intellectual Appeal

• Postmarket review strengths
• Quality system regulations
• Require quality assessment
• Require process controls
• Require corrective actions

Intellectual Appeal

• Need for harmonization
• IVD directive
• JCTLM
• NIST/NCI/CAP initiatives

Office of IVDs

• Small number of players -- major structural change
• Merger of premarket with compliance and integration of postmarket into this unit

Office of IVDs

• Three divisions
• Compliance support staff
• Cross-office support

TPLC IVD Program

• Ideal target
• Stereotyped review issues
• Cadre of like minded scientists
• Rapidly emerging technologies
• Already multi-tasking

Office of IVDs

• What it means to stakeholders?
• Single organizational unit
• One stop shopping

Office of IVDs

• What it does not means?
• Change in premarket requirements
• Change in postmarket requirements

Office of IVDs

• What it could mean?
• Coordination improved
• Innovative programming encouraged with changes in business as usual
• Clearer expectations

Office of IVDs

• Objective -- TPLC
• Common technical base
• Faster response time
• Flatter more dynamic organization

Goals

• Increased transparency
• Uniform least burdensome approach
• Expedited technology transfer
• Improve connectivity and quality of work

New Initiatives

• OIVD web page
• Review checklist – template driven
• Lab Sun pilot of Med sun
• Enhanced leveraging

Help From Professional Groups

• Time studies for PAP smear readers
• HPV guidelines and consumer information
• TDM guidances
• Interest out of Quality Institute

Help from Industry Groups

• Input on review models
• Input on reporting for MDRs
• Input on QSRs

Fortuitous Timing

• Changing health care environment
• Changing regulatory environment
• Changing administrative environment -- equation tipped toward access to technology
• Technological revolution -- numbers down but innovations up

Precepts

• Search for forest instead of trees

Looking for Input

• Function
• Structure
• Introspective
• Reality checks

CLIA update

• 2000 classifications
• Increase in number of waived
• Menu fairly static

CLIA Complexity Determinations

• Assigned to FDA in 1992
• Transferred to CDC in 1994
• Proposed rule in 1995 -- standards based approach requiring no inaccuracy

CLIA Complexity Determinations

• Confounding language in FDAMA
• Interest in one stop shopping
• Transferred to FDA in 1999

Waiver Criteria

• Evolved over time
• Challenged by changing technology
• FDA public meeting -- broader criteria
• FDA guidance

CLIA Studies

• CMS pilot studies
• 32% labs lack instructions
• 32% have no QC
• 16% fail to follow instructions

Waiver Criteria

• CMS exerted authority
• Return to 1995 rule
• CMS working on refining authorities -- collaborative effort
• FDA active review following statute -- filtered through 1995 rule

CLIA Program

• Awkward transition
• HIV waiver
• No final chapter

Genetics -- "Home Brews"

• "Home Brews" -- unregulated devices
• SACGT recommendations on the table
• FDA outlined possible responses – detailed action plan
• SACGT disappeared
• Recommendations did not

Genetics Initiatives

• ACLA meeting -- Dan Troy did indicate regulation remains an option
• Active exploration of how to pursue this
• NPRM

Genetics Initiatives

• Industry input
• Professional input
• Final chapter not written

Diagnostics for Bioterrorism

• Diagnostics central
• CDRH not well funded
• Internal resource re-direction
• Independence

Diagnostics for Bioterrorism

• Complex regulatory issues and choices
• Complex scientific issues
• Fall out from environmental tests
• When is an environmental test diagnostic?

Good News

• FDA engaged in inter-departmental working groups
• Products in various stages of development
• Down-classifications in place -- de novo

Full Plate

• Emerging infectious diseases
• Microarrays
• POC testing/ OTC testing
• Expert systems

Good Science