# Presentation: 532609

## Update on a New Office – The FDA perspective on IVDs

- Steven Gutman, M.D.

## 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- Outdated law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