# Presentation: 751959

## FDA Regulation of In Vitro Diagnostic Devices

- Steven Gutman, M.D.

## IVD Update

- People
- Workload
- Performance
- Current Activities
- Least Burdensome
- Strategic Plan

## People	

- New Commissioner -- Dr. McClellan
- New Deputy Commissioner – Dr. Crawford
- New Chief Counsel – Dan Troy
- Seasoned Center Director – Dr. Feigal
- New Center Organization – Linda Kahan and Lillian Gill

## People	

- Deputy Office Director -- Don St. Pierre
- Deputy Division Directors -- Josie Bautista, Jean Cooper, Freddie Poole
- AD for Special Programs -- Joe Hackett
- Regulatory Program Advisor -- James Woods (detail)
- Legal Advisor for Regulatory Affairs -- Terri Garvin (detail)

## People	-- Programs

- Premarket Review
- CLIA categorization
- Genetics working group
- Bioterrorism initiatives
- TPLC initiative

## Number of Original 510(k)s

## Replacement ReagentsFebruary 2000 - November 2001

- _330_ add to the records for Replacement Reagents
- An average of _190_ per year
- Before CLIA the average was _81_ per year

## Decreased 510(k)s

- Liberalization in modifications policies
- Increased use of ASR rule
- Laboratory cost constraint environment

## FY02 510(k) Review Stats

## PMA Approvals

## Approvals by Type of PMA/S

## Other OIVD Documents

## CLIA Workload

## CLIA Complexity Determinations

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

## Waiver Process is Complex

- Waiver by regulation -- 8 analytes
- Waiver through OTC -- a dozen analytes
- Waiver through 1995 rule criteria -- a dozen analytes

## Non-Parallel

- OTC clearances are based on substantial equivalence standard
- Lay use equivalent to lab use
- Labeling is understandable
- Benefits outweigh risks

## CLIA Program

- Awkward transition
- Current problem in non-congruent QC labeling
- High visibility device under consideration
- No final chapter

## CLIA

- Need for education
- Opportunity for industry
- Opportunity for professional groups
- Opportunity for government

## Genetics -- “home brews”

- “Home Brews” -- unregulated devices
- SACGT recommendations on the table
- FDA outlined possible responses – detailed action plan
- Risk based approach -- CBER
- New review tools

## Pharmacogenomics

- Hackett initiative
- IVD version of Staff College
- Extensive internal and external outreach
- Two Round Tables -- Pharmacogenomics and TDM

## Genetics Initiatives

- Final chapter not written
- ACLA meeting -- Dan Troy did indicate regulation remains an option
- Active exploration of how to pursue this

## 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?

## Antimicrobial Resistance Initiatives

- FDA not central, diagnostics are
- Area needing increased attention
- Inter-departmental plan in place
- Searching for mechanisms to aid technology transfer in this area
- Displaced by interest in bioterrorism

## Industry Interests --  IVD Round Table

## Quality Submissions

- IVD Workshop
- In conjunction with AMDM
- Unique and popular

## Quality Guidances

- Guidances – Time and expertise intense
- Provide standardization
- Provide clarify
- Industry input
- FDA slow on uptake

## Collaborative Problem Identification/Solving

- Alternative site testing the rage
- Physiological problem identified
- FDA called a panel
- Industry formed glucose working group
- Industry directed guidance
- Peer pressure drove labeling

## Educational Outreach

- Clarify new programs
- Q and A’s
- Real Time PMA supplements
- De novo 510(k)s
- Pre-IDEs
- Posted on industry web pages

## Future Milestone --Labeling Initiatives

- Symbols
- International harmonized labeling -- ISO 212
- Better home use labeling
- Better labeling

## Laboratory Interests -- Professional Round Table

## Quality Submissions

- Clarification of program strengths and weaknesses
- Identification of collaborative activities
- Activist bridge AACC

## Quality Guidances

- Less experience
- Rich perspective

## Collaborative Problem Identification/Solving

- Communicate device issues
- Work with regulatory systems
- Develop better sharing of knowledge

## Meet User Needs

- Heterogeneous community
- Variable resources
- Cost constraints
- Variable expectations

## FDAMA	

- Improved market access
- Least burdensome pathways
- Premarket to postmarket balance
- Increased interaction with industry

## Least Burdensome	

- Appropriate questions
- Appropriate thresholds
- Non-academic pursuits

## Least Burdensome	

- Matter of law
- Matter of policy
- Matter of spirit

## Least Burdensome	

- Two Guidance Documents
- Systems Approach -- ensure appropriate process applied to use of regulatory tools
- Review Guidance

## Least Burdensome	

- Review changes are profound
- Parallel genetics

## Least Burdensome	

- Shift to data summaries
- Shift to more focused labeling review
- Shift to use of clinical literature
- Shift to postmarket

## Strategic Plan -- Goals

- Mission related
- Total Product Life Cycle
- Magnet for Excellence

## Total Product Life Cycle

- Cradle to grave
- Seamless oversight

## 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

- Product of cross office brain storming
- Not unique -- one program to promote TPLC
- 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 you?
- Single organizational unit
- One stop shopping

## Office of IVDs

- What it does not means to you?
- Change in premarket requirements
- Change in postmarket requirements

## Office of IVDs

- What it could mean to you?
- Coordination improved
- Innovative programming encouraged
- 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

## Knowledge Based Initiative

- Internal sharing
- External sharing
- IVD Web Page

## Patient Safety

- Transcend compliance and surveillance
- Emphasize education and information; enforcement when necessary
- Look at IVD specific refinements in existing programs

## Patient Safety

- MedSun pilot
- Improved use of data inputs
- Laboratory safety tips
- Patient safety tips

## 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

- Improved connectivity
- Improved communication
- Improved assessment
- Expanded leveraging
- Search for forest instead of trees

## Looking for Input

- Function
- Structure
- Introspective
- Reality checks

## Core Mission

- Promote public health
- Apply good science
- Evolving program
- Relevant, focused, safe and effective