Office of In Vitro Diagnostic Device Evaluation and Safety

Donald St.Pierre
Deputy Director for New Device Evaluation
AdvaMed’s 13^th Annual Device Submissions Workshop
June 4-5, 2003

[Powerpoint]

The Story Line

• Organization & Resources
• Workload
• Review Statistics
• MDUFMA

I. ORGANIZATION & RESOURCES

Structure - OIVD

• Single Organizational Unit
• Premarket
• Compliance
• Post-market
• One Stop Shopping
• Delayered – no more branches
• Streamlined – minimal administrative support
• Goals

• Increased Transparency
• Uniform Least Burdensome Approach
• Expedited Technology Transfer
• Improve Connectivity and Quality of Work

• Objective - TPLC
• Common Technical Base
• Faster Response Time

SEE ORGANIZATIONAL CHART

Thanks to MDUFMA

• Approaching FY01 Staffing Level

• 11^th Annual Workshop – 66
• 12^th Annual Workshop – 54
• 13^th Annual Workshop – 63

• Doug Wood (DCTD - 5/18)
• Cecily Jones (DIHD – 6/1)
• Marieanne Brill (DMD – 6/1)
• 3 more are in-process
• Total Projected --70-75 by EOY

Parallel to other offices

• ODE

• Same commitments, responsibilities
• Adopt spirit of LB, summaries/balance

• OC

• Same commitments, responsibilities
• Still learning, moving 510(k)s this direction, 30-day notice changes, tracking, MOU

• OSB

• Eggs in MedSun basket
• Move from MDRs to active surveillance

Other Offices - Projects

• OST

• Software support
• Guidance collaboration

• OHIP

• Still some pt labeling/human factors
• OIVD website

• OSM

• Collaborative software, databases, tracking, eReview

External Outreach

• IVD Roundtable
• Professional IVD Roundtable
• Pharmacogenomic Roundtable
• Therapeutic Drug Management RT
• Internal Staff College
• NIH/NCI
• CDC/CMS
• SAMHSA

II. WORKLOAD

PMA Receipts (½ FY03)

510(k) Receipts (½ FY03)

Other OIVD Documents

Other Receipts (½ FY03)

Standards Activities

• 5 revised
• 4 withdrawn
• 15 new

(See 4/28/03 FR notice)

GHTF

• CDRH active in all Study Groups (SG); OIVD active in SG 1 (POC - Ginette Michaud)
• SG1: operational aspects of medical device regulation including IVD products

Current IVD harmonization projects:

• classification
• labeling
• IVD premarket conformity with principles for safety and performance

• STED (?)

FY03 Guidance Documents

• Multiplex Tests for Heritable DNA Markers, Mutations and Expression Patterns
• Antimicrobial Susceptibility Test (AST) Systems
• Analyte Specific Reagents; Small Entity Compliance Guidance

Guidances In-the-Works

• Coagulation
• NIOX and 1 other Denovo
• Replacement Reagent
• Glucose
• IVD Device Studies (BiMo)

OIVD Counter Terrorism Activities

• Established emergency response plans, in conjunction with HHS and FDA, to monitor and respond to a terrorist event 
• Expediting the review of device submissions related to counter terrorism and military need
• Evaluating the safety and effectiveness of diagnostic test kits that detect biothreat agents
• Participated in TOPOFF Exercise

Other Resource Issues

• Classifications – Herpes, B. Anthracis, Yersinia Pestis
• Scorecards
• CBER/CDRH interactions
• CPI
• TPLC/Patient Safety
• SARS/WNV
• ASRs/Genetics
• CLIA/OC

On the Web FY03

• 510(k) - IDI Strep B for Preg. Women
• 510(k) - pro-BNP for CHF
• 510(k) - Home Glycated Hemoglobin for Diabetics
• 510(k) - Cobalt Albumin to rule out Heart Attack
• 510(k) - Breath test for Asthma
• 510(k) - Aspergillus

On the Web FY03

• Lab Safety Tips
• Accu Chek class II Recall
• SSED - P020027 (FPSA)
• SSED - P020011 (HCV)
• IVD 510(k) Workshop
• Expanded use for HPV
• Consumer Information

Ongoing Activities

• Performance Scorecards

• Looking for measurable outcomes (e.g.,)

• Decrease enforcement actions
• Decrease recalls
• Decrease MDRs
• Decrease review times
• Increase decision quality
• Improve BiMo audit results
• Measure feedback

Ongoing Activities

• New IVD Webpage (good first effort)
  www.fda.gov/cdrh/oivd
• Standardizing review format
• Learning about compliance
• Learning about post-market
• MedSun to LabSun
• Post-market safety team

Post-Market Safety Team - Themes

• Consumer education/outreach
• Internal training (522 authority, STAMP, safety alerts,
  public health advisories/notifications, MDRs, MedWatch, MedSun)
• Tap Epi group – databases/literature
• Pick a disease and focus
• Active Surveillance ideas

III. REVIEW STATISTICS

Original PMA Approvals

PMA Supplement Approvals

½ FY03 510(k) Review Stats

510(k) Review Stats

CLIA Workload

IV. MDUFMA

Participating on implementation teams

Providing input on Guidances

Clarifying terminology

Bundling

Bundling Principles

• Historically Done – continue
• Not Historically Done – don’t, unless it makes sense & can be reviewed efficiently
• Second thoughts on our part (e.g., HBV)
• Guidance Coming
• No fee for Replacement Reagents

Challenges for the New Millennium

• CLIA waiver
• Genetic Diseases/ASRs
• Microarrays/High throughput assays
• Turbo 510(k)
• TPLC
• Integrating all the work of the Center into OIVD